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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
510(k) Number K855228
Device Name FEMORAL HEMI-HIP PROSTHESES
Applicant
Orthopaedic Device Corp.
6 Forest Ave.
Paramus,  NJ  07652
Applicant Contact ALEX KHOWAYLO
Correspondent
Orthopaedic Device Corp.
6 Forest Ave.
Paramus,  NJ  07652
Correspondent Contact ALEX KHOWAYLO
Regulation Number888.3360
Classification Product Code
KWL  
Date Received12/30/1985
Decision Date 02/11/1986
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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