Clearance Summary
Latitud Hip Replacement System received FDA 510(k) clearance under submission number K222436, sponsored by Meril Healthcare Pvt. , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-05-09.
- Submission: K222436
- Applicant / Sponsor: Meril Healthcare Pvt. , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2023-05-09
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.