510(k) K090103
100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL by
Biomet, Inc.
— Product Code MAY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 11, 2009
- Date Received
- January 15, 2009
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type