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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 K060577
Device Name ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
Applicant
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Applicant Contact WILLIAM J GRIFFIN
Correspondent
Ortho Development Corp.
12187 S. Business Park Dr.
Draper,  UT  84020
Correspondent Contact WILLIAM J GRIFFIN
Regulation Number888.3353
Classification Product Code
LZO  
Date Received03/06/2006
Decision Date 04/28/2006
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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