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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/Polymer, Porous Uncemented
510(k) Number K933882
Device Name OSTEONICS PS HEMI-HIP STEM SERIES
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact ROBERT A KOCH
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact ROBERT A KOCH
Regulation Number888.3358
Classification Product Code
LPH  
Date Received08/10/1993
Decision Date 08/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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