Clearance Summary
MULTIFIT TOTAL HIP SYSTEM received FDA 510(k) clearance under submission number K101472, sponsored by Otis Biotech Co., Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-01-05.
- Submission: K101472
- Applicant / Sponsor: Otis Biotech Co., Ltd.
- Clearance pathway: Abbreviated
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2011-01-05
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.