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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K183114
Device Name Corin BiPolar-i
Applicant
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Applicant Contact Homer Trieu
Correspondent
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Correspondent Contact Homer Trieu
Regulation Number888.3390
Classification Product Code
KWY  
Date Received11/09/2018
Decision Date 06/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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