K251224
- 510(k) number
- K251224
- Device name
- Restrata Soft Tissue Reinforcement (STR)
- Applicant
- Acera Surgical, Inc. MO · US
- Product code
- OXF — Mesh, Surgical, Absorbable, Plastic And Reconstructi
- Decision date
- 2025-06-20
- Date received
- 2025-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251224.pdf
Official FDA record: K251224
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.