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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 cemented acetabular component)
510(k) Number K922861
Device Name BIOMETRIC SCREW FIXATION CUP
Original Applicant
OSTEO TECHNOLOGY, INC.
10 west aylesbury rd.
timonium,  MD  21093
Original Contact sam son
Regulation Number888.3320
Classification Product Code
JDL  
Date Received06/04/1992
Decision Date 05/12/1993
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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