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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 K081127
Device Name ACCIN TOTAL KNEE SYSTEM
Applicant
Accelerated Innovation, LLC
1033 Us Hwy. 46e
Suite A204
Clifton,  NJ  07013
Applicant Contact MICHAEL KVITNITSKY
Correspondent
Accelerated Innovation, LLC
1033 Us Hwy. 46e
Suite A204
Clifton,  NJ  07013
Correspondent Contact MICHAEL KVITNITSKY
Regulation Number888.3560
Classification Product Code
JWH  
Date Received04/21/2008
Decision Date 10/17/2008
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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