K253145
- 510(k) number
- K253145
- Device name
- Pre-Sutured Tendon
- Applicant
- Rti Surgical, Inc. FL · US
- Product code
- GAT — Suture, Nonabsorbable, Synthetic, Polyethylene
- Decision date
- 2025-10-22
- Date received
- 2025-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K253145.pdf
Official FDA record: K253145
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.