Clearance Summary
SPAR-K Instruments (for use with Gemini SL Total Knee System) received FDA 510(k) clearance under submission number K191755, 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 2019-07-18.
- Submission: K191755
- Applicant / Sponsor: Waldemar Link GmbH & Co. KG
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2019-07-18
Classification & Regulation
This clearance is catalogued under FDA product code JWH and 21 CFR 888.3560, within the Orthopedic review panel as a Class II device.