Clearance Summary
Acetabular Bone Screws (for MobileLink Acetabular Cup System) received FDA 510(k) clearance under submission number K192559, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-12-21.
- Submission: K192559
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2019-12-21
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.