T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System

Rod, Fixation, Intramedullary And Accessories

Stryker GmbH

The following data is part of a premarket notification filed by Stryker Gmbh with the FDA for T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (gtn),t2 Ankle Arthrodesis Nail,t2 Arthrodesis Nail System.

Pre-market Notification Details

Device IDK200880
510k NumberK200880
Device Name:T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactJackie Perri
CorrespondentJackie Perri
Stryker GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-02
Decision Date2020-07-01

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