Tendon Anchor— 510(k) K263461
Substantially EquivalentSmith & Nephew, Inc.
FDA 510(k) clearance K263461 for Tendon Anchor, Substantially Equivalent on 2026-10-27. Applicant: Smith & Nephew, Inc.. Device class: 2.
Clearance details
- Applicant
- Smith & Nephew, Inc.
- Product code
- Product code GDW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4750
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Andover, MA, US
Recent devices under product code GDW
view allMore clearances from Smith & Nephew, Inc.
view all- K263348 — Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue +5 more
- K261462 — LANDMARK Total Knee System
- K261968 — Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981) +1 more
- DEN250037 — TESSA Spatial Surgery System; INTELLIO Tablet (72205455)
- K254084 — AETOS Shoulder System - CONCELOC Glenoids
Adverse events under product code GDW
product code GDW- Death
- 450
- Injury
- 12,684
- Malfunction
- 68,730
- Other
- 6
- Total
- 81,870
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.