MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

PROTEK, INC.

The following data is part of a premarket notification filed by Protek, Inc. with the FDA for Modified Protasul 100 (ti-6a1-7nb) Alloy.

Pre-market Notification Details

Device IDK861988
510k NumberK861988
Device Name:MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant PROTEK, INC. 5780 WEST 71ST ST. Indianapolis,  IN  46278
ContactKenneth Epling
CorrespondentKenneth Epling
PROTEK, INC. 5780 WEST 71ST ST. Indianapolis,  IN  46278
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-09
Decision Date1987-02-11

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