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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K971435
Device Name HEADLOC CERAMIC FEMORAL HEADS
Applicant
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER,  UT  84020
Applicant Contact CAROL J FREASIER
Correspondent
ORTHO DEVELOPMENT CORP.
106 WEST 12200 SOUTH
DRAPER,  UT  84020
Correspondent Contact CAROL J FREASIER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/18/1997
Decision Date 07/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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