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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 Uncemented Acetabular Component)
510(k) Number K842466
Device Name TITANIUM MITTELMEIER TYPE ACETABULAR
Applicant
American Ortomed Corp.
72 Beechwood Ave.
Poughkeepsie,  NY  12603
Applicant Contact MICHAEL M STEK
Correspondent
American Ortomed Corp.
72 Beechwood Ave.
Poughkeepsie,  NY  12603
Correspondent Contact MICHAEL M STEK
Regulation Number888.3330
Classification Product Code
KWA  
Date Received06/25/1984
Decision Date 01/30/1985
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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