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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 K982389
Device Name ODC B2 BIPOLAR CUP
Applicant
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Applicant Contact CAROL FREASIER
Correspondent
Ortho Development Corp.
106 W. 12200 S.
Draper,  UT  84020
Correspondent Contact CAROL FREASIER
Regulation Number888.3390
Classification Product Code
KWY  
Date Received07/09/1998
Decision Date 10/07/1998
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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