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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 K101032
Device Name CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
Applicant
Cardo Medical, Inc.
10 Clifton Blvd.
Suite B1
Clifton,  NJ  07011
Applicant Contact MICHAEL KVITNITSKY
Correspondent
Cardo Medical, Inc.
10 Clifton Blvd.
Suite B1
Clifton,  NJ  07011
Correspondent Contact MICHAEL KVITNITSKY
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
LZN  
Date Received04/14/2010
Decision Date 07/08/2010
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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