510(k) K200607
K200607 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Waldemar Link GmbH & Co. KG has at least 10 other 510(k) clearances on record.
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