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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, uncemented, metal / polymer, non-porous, calcium phosphate
510(k) Number K954800
Device Name APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
Applicant
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Applicant Contact BARRY J HASSETT
Correspondent
INTERMEDICS ORTHOPEDICS
9900 SPECTRUM DR.
AUSTIN,  TX  78717
Correspondent Contact BARRY J HASSETT
Regulation Number888.3353
Classification Product Code
MEH  
Date Received09/27/1995
Decision Date 04/25/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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