Clearance Summary
LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation received FDA 510(k) clearance under submission number K222278, sponsored by Corentec Co., Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2022-08-26.
- Submission: K222278
- Applicant / Sponsor: Corentec Co., Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2022-08-26
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.