T2 ICF

Screw, Fixation, Bone

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for T2 Icf.

Pre-market Notification Details

Device IDK193366
510k NumberK193366
Device Name:T2 ICF
ClassificationScrew, Fixation, Bone
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactCindy Leon
CorrespondentCindy Leon
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-04
Decision Date2020-03-20

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