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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 K210695
Device Name CPM Medical Consultants Tibial Revision Knee System
Applicant
Cpm Medical Consultants, LLC
1565 N. Central Expressway
Richardson,  TX  75080
Applicant Contact Andy Rynearson
Correspondent
Cpm Medical Consultants, LLC
1565 N. Central Expressway
Richardson,  TX  75080
Correspondent Contact Andy Rynearson
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/08/2021
Decision Date 08/16/2021
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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