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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 K861988
Device Name MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
Applicant
Protek, Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Applicant Contact KENNETH EPLING
Correspondent
Protek, Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Correspondent Contact KENNETH EPLING
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/09/1986
Decision Date 02/11/1987
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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