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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 uncemented acetabular component)
510(K) Number K851404
Device Name OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES
Applicant
OSTEONICS CORP.
59 route 17
allendale,  NJ  07401 1677
Contact dennis h crane
Regulation Number888.3330
Classification Product Code
KWA  
Date Received04/09/1985
Decision Date 06/18/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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