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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K240875
Device Name Unity Knee PS-C Tibial Insert
Applicant
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Applicant Contact Marine De Paoli
Correspondent
Corin U.S.A. Limited
12750 Citrus Park Ln.
Tampa,  FL  33625
Correspondent Contact Marine De Paoli
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/29/2024
Decision Date 06/26/2024
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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