The Orthopedic Design & Technology Manufacturers Capabilities Gallery highlights the web and literature of advertisers in this issue. To receive more information on these companies, visit their sites directly.
Accutek Testing Laboratory
For over 20 years, major companies across industries, including aerospace, medical, power generation and manufacturing, have turned to Accutek for their product conformance, materials identification, and failure analysis needs. Accutek's network of engineering professionals and full-service testing facility will provide the critical knowledge, personalized service and timely delivery of your testing requirements.
Boyd Coatings Research Co., Inc.
Boyd Coatings Research Co. manufactures, applies, and distributes custom-developed, high-performance coatings to meet specific medical device needs. High-volume and flexible manufacturing capabilities allow the company to produce both large and small quantities quickly and cost-effectively. Boyd is a Licensed Industrial Applicator of Teflon®.
Bradshaw Medical
Bradshaw Medical gives you the competitive edge in today’s highly specialized design & development of OEM orthopedic and spinal surgical instruments. We manufacture world class instruments from the highest quality materials to meet your most demanding requirements. Our team is ready to work closely with your staff in providing solutions to the challenges of today’s highly competitive marketplace. We have the Experience, Vision, and State-of-the-Art R&D and manufacturing capabilities to be able to develop innovative instruments in time for your next critical product launch.
C5 medicalwerks
A leading provider of ceramic solutions for medical device industries, C5 Medical Werks offers state-of-the-art manufacturing equipment, advanced ceramic materials, and a comprehensive quality system -- including certification to ISO 13485:2003. Product lines include ceramic implantable components used in hip, spine, dental, and custom implant components.
Donatelle
Donatelle is an FDA compliant, ISO-9001:2000 and ISO-13485:2003 certified supplier with expertise in machined metal fabrication. Our diverse list of capabilities includes: 5-, 7-, and 11-axis Swiss CNC machining with tolerances to ± .0002 or less, wire and plunge EDM, 5-axis machining, de-burring, precision cleaning and finishing, as well as welding resistance and laser. In addition, Donatelle offers micro machining for part features under 0.005” with inspection accuracy to 0.00002”.
DOT GmbH
DOT offers an extensive range of surface treatments for orthopaedic implants and instruments such as: PVD (TiN) coatings; Plasma Sprayed Titanium coatings; Electro-chemical CaP deposition (BONIT® coating) and Anodic oxidation (DOTIZE®). Additional business areas are: Nano-porous bone graft substitute BONITmatrix®; manufacturing services (CNC-machining of implants/surgical instruments).
ISO 13485:2003 certified.
Eagle Stainless Tube
Purchase a Lab Sample Kit on-line. The Kit features a large assortment of 300 series stainless steel hypodermic tubing well suited for test, evaluation and prototyping by designers and laboratory personnel. The kit includes 81 pieces of 40” long hypodermic tubing in a full range of sizes from 6 gauge to 33 gauge – all with a variety of wall thicknesses.
Electrolizing Corporation of Ohio
MEDCOAT 2000TM, developed by The Electrolizing Corp. of OHIO, significantly improves the appearance and service life of medical devices, increases resistance to wear and prevents corrosion. Ti-Med Titanium Anodizing is a safe process that colors without dyes and can be used on medical parts, components and instruments. ISO 9001:2000. Biocompatible per ISO 10993. Visit www.electrohio.com or www.medcoat2000.com.
EtQ Inc.
EtQ Inc. is the leading enterprise quality and compliance management system to identify, mitigate and prevent highrisk events through automation, integration and collaboration.
EtQ Inc. uses best of breed integrated modules and enterprise application integration to manage the process, provide business intelligence visibility and execute organizational change.
Fischer Connectors
Fischer Connectors designs, manufactures and distributes sleek, high-performance connectors. Known for their reliability and precision, Fischer's products are used in fields requiring faultless quality. Their metal, plastic, hybrid and disposable connector series are ideally suited for use in the testing and instrumentation, military, broadcast, and medical applications.
Fort Wayne Metals
At Fort Wayne Metals, we never lose sight of the fact that the wire we draw will end up in medical devices used to save lives. It is this philosophy that has allowed us to grow from a small wire mill in 1970 to the market leader for precision fine wire for medical products throughout the world. We have four manufacturing facilities in Fort Wayne, Indiana and a 2700 m2 manufacturing and warehousing facility in Castlebar, County Mayo, Ireland.
Gibraltar Laboratories
This 35-year old company has an international reputation for quality services and testing in Bacteriology, Mycology, Virology, Chemistry and Packaging. The company, headed by Daniel L. Prince, Ph.D., operates laboratories in Fairfield, NJ. Gibraltar Laboratories performs rapid and accurate testing services under cGMP at reasonable prices in a timely manner. Further, the company is unique in that all departments are headed by Ph.D. or master’s level scientists with prior experience in industry or academia, it has a research policy that has resulted in over 60 papers or publications in the archive or trade literature it maintains contacts with regulatory or compendial personnel in FDA, EPA and USP.
Guyson Corporation
Guyson Corporation’s on-line home offers an overview of the blast machine manufacture’s line-up of automated blasting systems and manual blast cabintes, as well as the full spectrum of cleaning, finishing and surface preparation applications. The site has detailed descriptions of dozens of different automatic blast machines, including workcell-sized beadblast equipment.
Incision Tech
IncisionTech manufactures cutting, piercing, and delivery systems for surgical devices. Our Center Of Excellence is where applied science improves cutting and piercing device performance. Products include surgical blades, trocars, custom scalpels, endoscopic scissors, tissue cutters, biopsy punches, sharpened tubes, specialty access needles, probes, tips, cannula, stylets, shaver blades and bone saws.
Lavezzi Precision Inc. 1908-2008 A Century of Quality
LaVezzi Precision, Inc., an ISO certified contract manufacturer, specializes in complex, burr-free, high-precision machining of implants and device components with tolerances to .000040". Multi-faceted parts are machined with the latest technology, including 9-axis Swiss CNCs, turning with C and Y axis, 5-axis CNC milling, full C-axis grinding and a Rollomatic grinder for cutting instruments. Parts are delivered exact to requirements on the date required.
Medical Device Consultants, Inc.
MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative “hands-on” solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle.
Microcision LLC
Microcision LLC, a contract manufacturer serving medical OEMs. offers ultraprecision CNC Swiss and CNC machining centers, EDM, and milled implants, components, and assemblies. The company serves the dental, orthopedics, neurological, spinal, and instrumentation industries. Materials include titanium, cobalt chrome, stainless steel and other difficult-to-machine metals, and plastics. Microcision is FDA registered and ISO 9001:2000 and ISO 13485:2003 certified.
Miltronics & Skye
Miltronics & Skye is a contract manufacturer servicing the medical device market. Miltronics has the manufacturing expertise in place to deliver an exceptionally high quality product within extremely tight time parameters. We have built our reputation on manufacturing complex geometrical medical devices including cervical and small bone fixation plates, polyaxial and monoaxial bone screws, hooks and rod connectors. We employ more than 100 of the nation’s most skilled engineers and manufacturing specialists. In addition to our world-class engineering support, Miltronics also has state-of-the-art manufacturing technology including the latest CC Swiss turning equipment and high-speed milling equipment. Miltronics & Skye is FDA registered and ISO 13485 certified.
Miraclean Ultrasonics
Miraclean provides high performance ultrasonic cleaning equipment and chemistries for parts and mold cleaning, parts washers with agitation and ultrasonics, passivation lines (nitric or citric), and liquid penetrant inspection lines. Systems may be single tanks or multiple station lines and may be manual or automated.
Oberg Industries
Oberg Industries provides technological leadership and manufacturing solutions to support OEM's focused on Orthopaedic, Spinal, and Trauma markets. Specialize in precision grinding, multi-axis machining, wire and plunge EDM, near-net stamping, surface finish development, and automated manufacturing and assembly systems. A $125 million company employing over 800 craftmen, that supports volume product launches, prototype and first article development.
Omni Components
Omni is an ISO 9001 & 13485 manufacturer of precision machining services and engineered solutions to the medical industry. CNC Swiss to 1 1/4 in. diameter, mill/turn lathe to 2 3/4 in. diameter, milling, prototyping, laser marking, EDM, assembly and turnkey support for a complete part.
Orchid Orthopedic Solutions
Orchid Orthopedic Solutions is a worldwide leader in contract design and manufacturing solutions for the orthopedic, dental and cardiovascular markets. Our mission is to be the leader in contract medical design and manufacturing by compressing time to market, providing new technology, and being the best total supply-chain value.
Paragon Medical
Paragon Medical is a tier 1, turnkey supplier of world-class solutions for cases and trays, surgical instrumentation, implantable components, and design services to the medical device marketplace. Headquartered in the orthopaedic capital of the world, Paragon has created strategic centers of excellence within the United States, Europe and Asia. Dynamic acquisitions have brought some of the industry's most talented craftsmen to our team while regional centers of manufacturing excellence have made us more versatile.
Precimed, Inc.
Precimed, a division of Greatbatch (NYSE: GB) is a manufacturer and developer of orthopedic products. ISO 9001:2000 and 13485:2003 certified; CE mark for standard products and FDA registered. Manufacturing sites include full product surface finishing capabilities, automated product flow controls and CAD/CAM interface. Manufacturing facilities are located throughout Switzerland and the US.
Precision Edge
Founded in 1989 we have grown into a world class contract manufacturer and we want to be your supplier of choice. We offer full in-house engineering and process capabilities and are ready to help you with your design and machining needs. ISO 13485:2003 Registered. Visit our website for more information.
Precision Medical Products
Precision Medical Products, Inc., the preferred choice for medical device outsourcing, represents over 50 years of experience in manufacturing, assembly and packaging of medical devices incorporating a variety of metalworking and plastic molding technologies for the leading pharmaceutical and medical device suppliers worldwide. For more information visit our website www.pmp.net.
Reading Alloys, Inc produces a wide range of medical grade titanium and alloy powders for orthopedic implant applications. Medical Grade CP-Ti (Grades 1-4) and Ti-6Al-4V (Grade 5 & ELI) powders are Nadcap certified to ASTM F1580-01 chemistry. Hydride-Dehydride (HDH) powders are available with controlled particle sizes from -50 mesh to -325 mesh. Morphologies include solid, angular and sponge types. Other markets served include near shape, PIM and wire markets.
Sandvik
Sandvik is a global industrial group with advanced products and a world-leading partner to medical OEMs across the globe. Operating in 130 countries, the Company offers leading-edge expertise in the production of orthopedic and spinal implants and instruments. Sandvik´s expertise includes R&D, materials technology and development, surface and powder technology, coatings, casting, forging and machining. The Company also offers a wide range of advanced material product forms for the medical segment.
Seabrook International
Seabrook International is a leading contract manufacturer of highly-engineered precision instruments, implants, and other devices for the orthopedics industry. Seabrook has become an integral supplier to several of the world’s largest orthopedic device manufacturers through its differentiated approach to customer service. At Seabrook, we are dedicated to our customers’ success.
Specialized Medical Devices
Implants – Instruments – Class 10,000 Clean Room Packaging. SMD specializes in complete spinal implant systems, small bone implant systems as well as custom orthopedic instrumentation. SMD is a full service manufacturer from prototype runs to full production. SMD’s expansive inhouse capabilities include: Ultra precise CNC-Swiss screw machining, 5-axis vertical milling, wire EDM, titanium anodization, a validated implant cleaning process, heat treating, laser marking, anodizing, electropolishing and passivation. Materials: titanium, stainless steel, cobalt chrome and Peek. FDA registered, ISO 13485:2003 certified.
Summit Corporate Services, Inc.
Summit Corporate Services, Inc. is a leading outsource provider of customizable inventory management, customer service, distribution, logistics and order fulfillment solutions for the medical device and biotech industries. At Summit, our goal is to offer the industry’s most comprehensive and specialized outsourcing services that enable our clients to control costs, ensure regulatory compliance, streamline operations and maximize profits.
Symmetry Medical, Inc.
Specializing in product development, professional services, project management, manufacturing, prototyping, Symmetry Medical makes it easier to get your products to market faster. With Symmetry Medical Total Solutions®, every detail of product development, from idea generation through quality assurance, is handled by Symmetry saving you time and money. With 200+ years of experience in design and manufacture of implants, instruments, and cases, our team will ensure quality customer service and design. ISO 13485:2003, FDA-registered ISO 9001:2000, EN 46002:1997, EN 46001, CE Marking, Environmental ISO 14001:1996/2004.
Tecomet
Tecomet is an innovative manufacturing partner with the capacity and flexibility to perform under extreme conditions. With a new dedicated Process Development Center and cutting-edge manufacturing techniques, we bend over backwards to provide engineered solutions, contain costs and reduce time-to-market. State-of-the-art technologies, innovative, on-demand manufacturing, and flexible management has made Tecomet a leader for more than 30 years.
Veridiam
Veridiam Medical is a contract manufacturer serving the Endoscopy/Arthroscopy, Dental/Orthodontic, Orthopaedic & Vascular OEM's. Capabilities include complex mechanical assemblies, Swiss Style Machining, EDM, Multi-Axis CNC Turning & Milling, Laser Cutting, Metal tube drawing/Forming, Cannulated Bar Drawing. We feature advanced capabilities to low cost machining at 4 facilities worldwide.
Vulcanium Metals Incorporated
Vulcanium® Metals Incorporated, a leader in the distribution of titanium mill products, stocks sheet, plate, shapes, bar and billet, cut to size, for medical implants, instrumentation and other applications. Next day shipping from stock. AS 9100/ISO 9000:2001 registered.
