T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System

Rod, Fixation, Intramedullary And Accessories

Stryker Trauma Gmbh

The following data is part of a premarket notification filed by Stryker Trauma Gmbh with the FDA for T2 Alpha Femur Antegrade Gt/pf Nailing System, Imn Screws System, Imn Instruments System.

Pre-market Notification Details

Device IDK172774
510k NumberK172774
Device Name:T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen,  DE 24232
ContactHeike Gustke
CorrespondentHeike Gustke
Stryker Trauma Gmbh Prof-Kuentscher-Str. 1-5 Schoenkirchen,  DE 24232
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-14
Decision Date2018-01-12
Summary:summary

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