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ISO 13485:2016

Arthrex, Inc.
1370 Creekside Boulevard
Naples
Florida
34108-1945
USA

Certificate Number: FM 84661
Scope: The design, development, and manufacture, servicing, installation and distribution of sterile and non-sterile metallic, non-metallic, and bio-absorbable implants and associated instrumentation, surgical procedure kits, sutures, total and hemi joint replacement devices and associated software and instrumentation, arthroscopic and minimally invasive surgical instruments, arthroscopes, electromechanical/electrosurgical ablation, cutting, drilling, visualization and fluid management devices and accessories, blood cell separators, centrifuges, sterile disposable processing sets, and sterile wound dressings.

Original Registration Date	Effective Date	Last Revision Date	Expiry Date
2004-05-21	2025-11-22	2026-03-06	2028-11-21

Site Name	Site Address	Certificate/License number	Standard/Scheme number or name
Arthrex, Inc.	1370 Creekside Boulevard Naples USA	FM 84661	ISO 13485:2016
Arthrex, Inc.	1360 Creekside Boulevard Naples USA	FM 84661	ISO 13485:2016
Arthrex California Technology, Inc.	460 Ward Drive Santa Barbara USA	FM 84661	ISO 13485:2016
Arthrex, Inc.	1265 Creekside Parkway Naples USA	FM 84661	ISO 13485:2016
Arthrex Logistics Center	14550 Plantation Road Fort Myers USA	FM 84661	ISO 13485:2016
Arthrex, Inc.	6875 Arthrex Commerce Drive Ave Maria USA	FM 84661	ISO 13485:2016
Arthrex GmbH	Erwin-Hielscher-Strasse 9 München Germany	FM 84661	ISO 13485:2016
Arthrex GmbH	OsKar-von-Miller-Strasse 6 Odelzhausen Germany	FM 84661	ISO 13485:2016
Arthrex, Inc.	6861 Arthrex Commerce Drive Ave Maria USA	FM 84661	ISO 13485:2016
Arthrex Manufacturing, Inc.	Building A & B 130 Arthrex Drive Pendleton USA	FM 84661	ISO 13485:2016
Arthrex Inc.	One Arthrex Way Naples USA	FM 84661	ISO 13485:2016
Arthrex Manufacturing	Building C 130 Arthrex Drive Pendleton USA	FM 84661	ISO 13485:2016