K250997
- 510(k) number
- K250997
- Device name
- Integrity Implant
- Applicant
- Anika Therapeutics, Inc. MA · US
- Product code
- OWX — Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinfo
- Decision date
- 2025-06-17
- Date received
- 2025-04-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250997.pdf
Official FDA record: K250997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.