510(k) clearance
OsseoFit Stemless Shoulder System
- 510(k) number
- K262955
- Applicant
- Zimmer, Inc.
- Decision date
- Sep 24, 2026
- Date received
- Aug 24, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- PKC
- Device type
- Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
- Device class
- Class II
- Regulation
- 21 CFR 888.3660
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Warsaw, IN, US