510(k) K230831
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 2023
- Date Received
- March 27, 2023
- 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