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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 Cemented Acetabular Component)
510(k) Number K870234
Device Name P.T.H. METAL-BACKED ACETABULAR CUP
Applicant
Orthopaedic Device Corp.
6 Pearl Ct.
Allendale,  NJ  07401
Applicant Contact ALEX KHOWAYLO
Correspondent
Orthopaedic Device Corp.
6 Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact ALEX KHOWAYLO
Regulation Number888.3320
Classification Product Code
JDL  
Date Received01/21/1987
Decision Date 03/20/1987
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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