FasTouch Absorbable Fixation System

Staple, Implantable

Via Surgical Ltd.

The following data is part of a premarket notification filed by Via Surgical Ltd. with the FDA for Fastouch Absorbable Fixation System.

Pre-market Notification Details

Device IDK181668
510k NumberK181668
Device Name:FasTouch Absorbable Fixation System
ClassificationStaple, Implantable
Applicant Via Surgical Ltd. Mitzpe Kineret Street 22/1 Moshav Amirim,  IL 2011500
ContactOfek Levin
CorrespondentLeo Basta
Northstar Biomedical Associates 93 Benefit Street Providence,  RI  02904
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-25
Decision Date2019-03-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290017155286 K181668 000
17290017155279 K181668 000
17290017155248 K181668 000
17290017155217 K181668 000

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