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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K212069
Device Name Corin MetaFix™ Hip Stem
Applicant
Corin USA Limited
5670 W. Cypress St., Suite C
Tampa,  FL  33607
Applicant Contact Janet Grannells
Correspondent
Corin USA Limited
5670 W. Cypress St., Suite C
Tampa,  FL  33607
Correspondent Contact Janet Grannells
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Codes
JDI   KWL   KWY   MEH   OQI  
Date Received07/02/2021
Decision Date 04/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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