510(k) K971721
WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD by
Whiteside Biomechanics, Inc.
— Product Code LZO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1997
- Date Received
- May 9, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type