Avalign Technologies designs and manufactures precision medical devices, including orthopedic implants and surgical instruments, with support from concept through launch and delivery. Its distinctive reach combines U.S. and German production with specialized capabilities such as proprietary porous coatings, precision-machined cutting instruments, and integrated supply-chain management. Avalign operates multiple dedicated facilities and maintains FDA registrations alongside ISO 13485 and MDSAP certifications across its manufacturing units.
FDA Registered — Avalign Technologies, Registration 3008864603
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ISO Certified — Avalign Technologies
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MDSAP Certified — Avalign Technologies
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FDA Registered — Avalign Additive / Slice Manufacturing Studios, Registration 3013413393
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ISO 13485 Certified — Avalign Additive / Slice Manufacturing Studios
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FDA Registered — Instruments and Implants, Registration 3006128100
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ISO 13485 Certified — Instruments and Implants
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FDA Registered — Cutting Instruments, Registration 1835251
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ISO 13485:2016 Certified — Cutting Instruments
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FDA Registered — Delivery Systems, Registration 1835444
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ISO 13485 Certified — Delivery Systems
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FDA Registered — German Specialty Instruments (Tuttlingen), Registration 8010372
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FDA Registered — German Specialty Instruments (Schaumburg), Registration 1421101
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ISO 13485 Certified — German Specialty Instruments
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FDA Registered — Integrated Medical Solutions, Registration 1527105
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ISO 13485 Certified — Integrated Medical Solutions
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FDA Registered — Thortex, Registration 3026776
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ISO 13485 Certified — Thortex
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FDA Registered — Millennium Surgical, Registration 3004215117
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Avalign Technologies, IncKnown for bringing advanced medical-device manufacturing under one roof, Avalign Technologies supports orthopedic and other surgical-device companies from early design through production. Its Akron operation, Avalign Additive, grew from Slice Manufacturing Studios and occupies a 35,000-square-foot facility with a 22-person team. The broader company also operates manufacturing facilities in Germany and the United States and holds ISO 13485 certifications across several units.AKRON, OH
ARCH Medical SolutionsARCH Medical Solutions brings together a nationwide network of FDA-registered facilities to contract-manufacture tight-tolerance medical implants, instruments, and components for OEMs. Its precision work spans orthopedic devices and surgical-robotics parts, with engineering support and prototype-through-production services built into the process. The company also develops MedTorque silicone-handled surgical instruments and operates under ISO 13485-certified quality systems.QUAKERTOWN, PA
Axial MedicalJust outside Philadelphia, Axial Medical is a dedicated contract manufacturer that takes medical implants from prototype through production, with a particular focus on complex spine and orthopedic work. Its 40,000-square-foot Warminster headquarters, custom-built in 2014, houses more than 60 five-axis CNC machines alongside in-house finishing and metrology capabilities. Axial Medical is ISO 13485:2016 certified and FDA registered.WARMINSTER, PA
ARCH Global PrecisionARCH Global Precision is an American precision-manufacturing company built around collaboration among engineers, machinists, and facilities across the country. It produces tight-tolerance components for medical OEMs and other demanding industrial customers, with ISO-certified and FDA-approved medical operations spanning more than 700,000 square feet.RUSSIA, OH