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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, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K221292
Device Name Uni Knee Resurfacing System
Applicant
Overture Resurfacing, Inc.
1617 3rd Ave., #287284
New York,  NY  10128
Applicant Contact Riley Williams
Correspondent
Cor Medical Ventures, Inc.
2010 Jimmy Durante Blvd., Suite 200
Del Mar,  CA  92014
Correspondent Contact Benjamin Arnold
Regulation Number888.3520
Classification Product Code
HSX  
Date Received05/04/2022
Decision Date 03/10/2023
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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