Clearance Summary
LINK CEMENTLESS SCREW-IN ACETABULAR CUP received FDA 510(k) clearance under submission number K843950, 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 1985-06-03.
- Submission: K843950
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class III
- Regulation citation: 21 CFR 888.3330
- Decision date: 1985-06-03
Classification & Regulation
This clearance is catalogued under FDA product code KWA and 21 CFR 888.3330, within the Orthopedic review panel as a Class III device.