510(k) K013042
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 2001
- Date Received
- September 10, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Constrained, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3150
- Review Panel
- OR
- Submission Type