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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K953977
Device Name PRIMALOC CEMENTLESS HIP SYSTEM
Applicant
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER,  UT  84020
Applicant Contact MICHELLE M PERRY
Correspondent
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER,  UT  84020
Correspondent Contact MICHELLE M PERRY
Regulation Number888.3390
Classification Product Code
KWY  
Date Received08/23/1995
Decision Date 01/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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