510(k) K960258
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 1996
- Date Received
- January 18, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type