Gamma3 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 Gamma3 System.

Pre-market Notification Details

Device IDK200869
510k NumberK200869
Device Name:Gamma3 System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant Stryker Trauma GmbH 325 Corporate Drive Mahwah,  NJ  07430
ContactSanja Jahr
CorrespondentSanja Jahr
Stryker Trauma GmbH 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-01
Decision Date2020-07-22

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