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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 K850793
Device Name MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
Original Applicant
INTERMEDICS ORTHOPEDICS
1300 east anderson ln.
building c
austin,  TX  78752
Original Contact thomas l craig
Regulation Number888.3320
Classification Product Code
JDL  
Date Received02/26/1985
Decision Date 05/09/1985
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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