K251690
- 510(k) number
- K251690
- Device name
- Arthrex SpeedFLEX Implant
- Applicant
- Arthrex, Inc. FL · US
- Product code
- OWY — Mesh, Surgical, Collagen, Orthopaedics, Reinforcemen
- Decision date
- 2025-09-30
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K251690.pdf
Official FDA record: K251690
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.