EXTREMITY MEDICAL SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

EXTREMITY MEDICAL LLC

The following data is part of a premarket notification filed by Extremity Medical Llc with the FDA for Extremity Medical Suture Anchor.

Pre-market Notification Details

Device IDK083151
510k NumberK083151
Device Name:EXTREMITY MEDICAL SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany,  NJ  07054
ContactJamy Gannoe
CorrespondentJamy Gannoe
EXTREMITY MEDICAL LLC 300 INTERPACE PARKWAY SUITE 410 Parsippany,  NJ  07054
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-24
Decision Date2009-01-22
Summary:summary

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