510(k) K061844
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 2006
- Date Received
- June 29, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device Class
- Class III
- Regulation Number
- 888.3320
- Review Panel
- OR
- Submission Type