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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
510(k) Number K903886
Device Name OSTEONICS SR GLENOID COMPONENTS
Applicant
Osteonics Reconstructive Products Div.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact PAT KRAMER
Correspondent
Osteonics Reconstructive Products Div.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact PAT KRAMER
Regulation Number888.3660
Classification Product Code
KWS  
Date Received08/22/1990
Decision Date 11/20/1990
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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