OptiFix AT Absorbable Fixation System With Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System With Articulating Technology - 15 Fasteners

Staple, Implantable

C.R. BARD INC.

The following data is part of a premarket notification filed by C.r. Bard Inc. with the FDA for Optifix At Absorbable Fixation System With Articulating Technology - 30 Fasteners, Optifix At Absorbable Fixation System With Articulating Technology - 15 Fasteners.

Pre-market Notification Details

Device IDK170278
510k NumberK170278
Device Name:OptiFix AT Absorbable Fixation System With Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System With Articulating Technology - 15 Fasteners
ClassificationStaple, Implantable
Applicant C.R. BARD INC. 100 CROSSINGS BOULEVARD Warwick,  RI  02886
ContactKatherine Earle
CorrespondentKatherine Earle
C.R. BARD INC. 100 CROSSINGS BOULEVARD Warwick,  RI  02886
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-30
Decision Date2017-05-31
Summary:summary

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