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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 K150496
Device Name Total Knee Arthroplasty System
Applicant
Responsive Orthopedics, LLC
1755 Concordia St.
Wayzata,  MN  55391
Applicant Contact Doug Kohrs
Correspondent
Cor Medical Ventures, LLC
101 N. Acacia Ave., Suite 106
Solana Beach,  CA  92075
Correspondent Contact Jude Paganelli
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/25/2015
Decision Date 06/12/2015
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
Recalls CDRH Recalls
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