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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 K971426
Device Name HEADLOC CERAMIC HEAD
Applicant
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Applicant Contact CAROL J FREASIER
Correspondent
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Correspondent Contact CAROL J FREASIER
Regulation Number888.3353
Classification Product Code
LZO  
Date Received04/17/1997
Decision Date 07/09/1997
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
Predetermined Change
Control Plan Authorized		 No
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