Clearance Summary
PATELLAR COMPONENT FOR LUBINUS PATELLAR received FDA 510(k) clearance under submission number K800800, 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 1980-04-21.
- Submission: K800800
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3580
- Decision date: 1980-04-21
Classification & Regulation
This clearance is catalogued under FDA product code HTG and 21 CFR 888.3580, within the Orthopedic review panel as a Class II device.