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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 K050966
Device Name PIVOT BIPOLAR FEMORAL HEAD
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 Number888.3390
Classification Product Code
KWY  
Date Received04/18/2005
Decision Date 07/07/2005
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
Recalls CDRH Recalls
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