Home / 510(k) Clearances / K201657

510(k) K201657

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 by Corin, Ltd. — Product Code LZO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2021
Date Received
June 18, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type

Other clearances by Corin, Ltd.

  • K200888 — OMNIBotics Knee System (June 27, 2020)

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  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)