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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K073068
Device Name ACCIN HIP 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 Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
HWC  
Date Received10/30/2007
Decision Date 01/10/2008
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
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