510(k) clearance
Tornier Humeral Reconstruction System (HRS) Tuberosity Body
- 510(k) number
- K263583
- Applicant
- Tornier, Inc.
- Decision date
- Oct 28, 2026
- Date received
- Sep 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- KWS
- Device type
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II
- Regulation
- 21 CFR 888.3660
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Bloomington, MN, US