Asnis JFX System

Screw, Fixation, Bone

Stryker Trauma AG

The following data is part of a premarket notification filed by Stryker Trauma Ag with the FDA for Asnis Jfx System.

Pre-market Notification Details

Device IDK153154
510k NumberK153154
Device Name:Asnis JFX System
ClassificationScrew, Fixation, Bone
Applicant Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
ContactGarry T. Hayeck
CorrespondentGarry T. Hayeck
Stryker Trauma AG 325 Corporate Drive Mahwah,  NJ  07430
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-02
Decision Date2015-12-28

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