510(k) K953607
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1996
- Date Received
- August 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fixation, Proximal Femoral, Implant
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type