510(k) K963100
TRONZO ACETABULAR FIXATION COMPONENT (1 99-02-00XX (ACE. FIXATION CUP) XX=OD OF ACE. CUP by
Endotec, Inc.
— Product Code LPH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1997
- Date Received
- August 9, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type