Clearance Summary
Corin Ltd. Hip Products: Trinity Acetabular System, Trinity PLUS Acetabular Shell, MetaFix Hip System, TriFit CF and TS Hip Systems, TaperFit Hip System, Revival Modular Hip System, MiniHip, Trinity Dual Mobility, MobiliT, BiPolar-i, OMNI MOD Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads received FDA 510(k) clearance under submission number K201657, sponsored by Corin, 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 2021-07-28.
- Submission: K201657
- Applicant / Sponsor: Corin, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2021-07-28
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.