Arthrex SpeedFLEX Implant— 510(k) K251690

Substantially Equivalent

Arthrex, Inc.

FDA 510(k) clearance K251690 for Arthrex SpeedFLEX Implant, Substantially Equivalent on 2025-09-30. Applicant: Arthrex, Inc..

Clearance details

Applicant: Arthrex, Inc.
Product code: Code OWY
Advisory panel: General, Plastic Surgery
Date received: 2025-06-02
Decision date: 2025-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

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