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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, Cemented
510(k) Number K901451
Device Name F-20 CEMENTED METAL-BACKED ACETABULAR CUP
Applicant
Med-Tek Corp.
6535 E. 82nd St.
Suite 215
Indianapolis,  IN  46250
Applicant Contact KENNETH EPLING
Correspondent
Med-Tek Corp.
6535 E. 82nd St.
Suite 215
Indianapolis,  IN  46250
Correspondent Contact KENNETH EPLING
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/02/1990
Decision Date 08/31/1990
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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