Clearance Summary
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE received FDA 510(k) clearance under submission number K211768, 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 2021-06-30.
- Submission: K211768
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3510
- Decision date: 2021-06-30
Classification & Regulation
This clearance is catalogued under FDA product code KRO and 21 CFR 888.3510, within the Orthopedic review panel as a Class II device.