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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Acetabular, Hip, Prosthesis
510(k) Number K925883
Device Name OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
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 Number878.3300
Classification Product Code
JDJ  
Date Received11/19/1992
Decision Date 06/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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