MAY HUMERUS PLATES

Plate, Fixation, Bone

TURNKEY INTERGRATION USA, INC.

The following data is part of a premarket notification filed by Turnkey Intergration Usa, Inc. with the FDA for May Humerus Plates.

Pre-market Notification Details

Device IDK912936
510k NumberK912936
Device Name:MAY HUMERUS PLATES
ClassificationPlate, Fixation, Bone
Applicant TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
ContactStuart
CorrespondentStuart
TURNKEY INTERGRATION USA, INC. 8021 KNUE RD. SUITE 121 Indianapolis,  IN  46250
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-05
Decision Date1991-09-06

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