510(k) K042344
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2005
- Date Received
- August 30, 2004
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type