510(k) K190535
K190535 is an FDA 510(k) premarket notification submitted by Waldemar Link GmbH & Co. KG for the device "BiMobile Dual Mobility System - E-Dur Inserts". The FDA issued a decision of Substantially Equivalent on Aug 6, 2019. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Waldemar Link GmbH & Co. KG has 42 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 6, 2019
- Date Received
- Mar 4, 2019
- Clearance Type
- Traditional
- 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
- 510(k)