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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
Applicant
ACE ORTHOPEDIC MANUFACTURING CO.
14105 south avalon blvd.
los angeles,  CA  90061
Applicant Contact janice l filippelli
Correspondent
ACE ORTHOPEDIC MANUFACTURING CO.
14105 south avalon blvd.
los angeles,  CA  90061
Correspodent Contact janice l filippelli
Regulation Number888.3320
Classification Product Code
JDL  
Date Received02/19/1992
Decision Date 07/27/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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