K251690

Substantially Equivalent

Arthrex SpeedFLEX Implant

Applicant: Arthrex, Inc.
Product 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.