INNOVASIVE 8MM LIGAMENT FASTENER

Fastener, Fixation, Nondegradable, Soft Tissue

INNOVASIVE DEVICES, INC.

The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive 8mm Ligament Fastener.

Pre-market Notification Details

Device IDK970316
510k NumberK970316
Device Name:INNOVASIVE 8MM LIGAMENT FASTENER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactEric Bannon
CorrespondentEric Bannon
INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-24
Decision Date1997-04-16
Summary:summary

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