510(k) K213580
Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length by
Total Joint Othopedics, Inc.
— Product Code LZO
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2021
- Date Received
- November 10, 2021
- 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, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3353
- Review Panel
- OR
- Submission Type