510(k) clearance
Tendon Anchor
- 510(k) number
- K263461
- Applicant
- Smith & Nephew, Inc.
- Decision date
- Oct 27, 2026
- Date received
- Sep 28, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- GDW
- Device type
- Staple, Implantable
- Device class
- Class II
- Regulation
- 21 CFR 878.4750
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Andover, MA, US