MultiFIX S Knotless Fixation System

Fastener, Fixation, Nondegradable, Soft Tissue

ArthroCare Corporation

The following data is part of a premarket notification filed by Arthrocare Corporation with the FDA for Multifix S Knotless Fixation System.

Pre-market Notification Details

Device IDK151660
510k NumberK151660
Device Name:MultiFIX S Knotless Fixation System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ArthroCare Corporation 15285 Alton Parkway, Suite 200 Irvine,  CA  92618
ContactLaura Kasperowicz
CorrespondentLaura Kasperowicz
ArthroCare Corporation 15285 Alton Parkway, Suite 200 Irvine,  CA  92618
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-06-19
Decision Date2015-07-16
Summary:summary

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