K243480
- 510(k) number
- K243480
- Device name
- SuturePatch Tissue Reinforcement
- Applicant
- Arthrex, Inc. FL · US
- Product code
- OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinfo
- Decision date
- 2025-05-29
- Date received
- 2024-11-08
- 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: K243480.pdf
Official FDA record: K243480
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.