K251098
- 510(k) number
- K251098
- Device name
- Identity Revision Humeral Stems
- Applicant
- Zimmer, Inc. IN · US
- Product code
- MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polyme
- Decision date
- 2025-08-11
- Date received
- 2025-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251098.pdf
Official FDA record: K251098
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.