510(k) K251098
K251098 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Identity Revision Humeral Stems". The FDA issued a decision of Substantially Equivalent on August 11, 2025. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 2025
- Date Received
- April 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3670
- Review Panel
- OR
- Submission Type