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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 K191831
Device Name MobiliT Cup
Applicant
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Applicant Contact Severine Siracusa
Correspondent
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Correspondent Contact Severine Siracusa
Regulation Number888.3353
Classification Product Code
LZO  
Subsequent Product Code
MEH  
Date Received07/09/2019
Decision Date 01/16/2020
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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