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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 K862460
Device Name FEMORAL HEMI-HIP PROSTHESIS
Applicant
Orthopaedic Device Corp.
C/O Cole Geaney Yamner & Byrne
P.O. Box D 100 Hamilton Plz.
Paterson,  NJ  07509
Applicant Contact ALEX KHOWAYLO
Correspondent
Orthopaedic Device Corp.
C/O Cole Geaney Yamner & Byrne
P.O. Box D 100 Hamilton Plz.
Paterson,  NJ  07509
Correspondent Contact ALEX KHOWAYLO
Regulation Number888.3390
Classification Product Code
KWY  
Date Received06/30/1986
Decision Date 10/06/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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