Clearance Summary
BiMobile Dual Mobility System - E-Dur Inserts received FDA 510(k) clearance under submission number K190535, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-08-06.
- Submission: K190535
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2019-08-06
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.