510(k) K070785
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 11, 2007
- Date Received
- March 21, 2007
- 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