Clearance Summary
OMNI TiN Coated Apex Knee System received FDA 510(k) clearance under submission number K191765, sponsored by Omni Life Science, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-09-25.
- Submission: K191765
- Applicant / Sponsor: Omni Life Science, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3560
- Decision date: 2019-09-25
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.