Surgimatix Absorbable Fixation System

Staple, Implantable

Surgimatix, Inc.

The following data is part of a premarket notification filed by Surgimatix, Inc. with the FDA for Surgimatix Absorbable Fixation System.

Pre-market Notification Details

Device IDK201934
510k NumberK201934
Device Name:Surgimatix Absorbable Fixation System
ClassificationStaple, Implantable
Applicant Surgimatix, Inc. 1539 Jarvis Ave Elk Grove Village,  IL  60007
ContactDorene Markwiese
CorrespondentDorene Markwiese
Surgimatix, Inc. 1539 Jarvis Ave Elk Grove Village,  IL  60007
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-13
Decision Date2021-10-01

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