510(k) K200607
LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters by
Waldemar Link GmbH & Co. KG
— Product Code LPH
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2021
- Date Received
- March 9, 2020
- 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