510(k) clearance
N22 Offset Humeral Head
- 510(k) number
- K262173
- Applicant
- Shoulder Innovations, Inc.
- Decision date
- Sep 8, 2026
- Date received
- Jun 26, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- KWT
- Device type
- Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- Device class
- Class II
- Regulation
- 21 CFR 888.3650
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Grand Rapids, MI, US