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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 K920738
Device Name ACE 100 DEGREES TUBULAR PLATE
Original Applicant
ACE ORTHOPEDIC MANUFACTURING CO.
14105 south avalon blvd.
los angeles,  CA  90061
Original Contact janice l filippelli
Regulation Number888.3320
Classification Product Code
JDL  
Date Received02/19/1992
Decision Date 07/27/1992
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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