Known 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.
FDA registered — Avalign Technologies — 3008864603
Registration
ISO Certified — Avalign Technologies
MDSAP Certified — Avalign Technologies
FDA registered — Avalign Additive | Slice Manufacturing Studios — 3013413393
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ISO 13485 Certified — Avalign Additive | Slice Manufacturing Studios
FDA registered — Instruments and Implants — 3006128100
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ISO 13485 Certified — Instruments and Implants
FDA registered — Cutting Instruments — 1835251
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ISO 13485:2016 Certified — Cutting Instruments
FDA registered — Delivery Systems — 1835444
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ISO 13485 Certified — Delivery Systems
FDA registered — German Specialty Instruments (Tuttlingen) — 8010372
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FDA registered — German Specialty Instruments (Schaumburg) — 1421101
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ISO 13485 Certified — German Specialty Instruments
FDA registered — Integrated Medical Solutions — 1527105
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ISO 13485 Certified — Integrated Medical Solutions
FDA registered — Thortex — 3026776
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ISO 13485 Certified — Thortex
FDA registered — Millennium Surgical — 3004215117
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FDA
Quality certification
FDAREGISTRATION
Quality certification
Avalign Technologies, IncAvalign 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.AKRON, OH
Accelerated OrthoSolutionsAccelerated OrthoSolutions is an Akron-based product development company serving the medical device community. It helps clients move devices from concept toward market, providing support at the stages where development, testing, or regulatory work is needed.UNIONTOWN, OH
Acrotec MedtechAcrotec Medtech is a Swiss-rooted collective of precision manufacturers built to work as one medical-manufacturing partner for OEMs. Its network spans more than 1,000 employees and 10-plus locations, combining the close technical collaboration of specialist shops with global production scale. The group’s companies are ISO 13485 certified and FDA-registered.WARMINSTER, PA
Infinite Medical SolutionsBuilt on more than 40 years of experience, Infinite Medical Solutions manufactures precision orthopedic and trauma implants and manages their engineering, processing, and assembly in Eastlake, Ohio. Its 200,000-square-foot facility on 14 acres is set up to scale complex medical-device projects, from spinal implant assemblies to micro-machined suture buttons. The company’s quality systems comply with ISO 9001, ISO 13485, and AS9100, reflecting its roots in aerospace as well as medical manufacturing.EASTLAKE, OH