INNOVASIVE 10MM LINX HT 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 10mm Linx Ht Ligament Fastener.

Pre-market Notification Details

Device IDK980334
510k NumberK980334
Device Name:INNOVASIVE 10MM LINX HT LIGAMENT FASTENER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactStephen Page
CorrespondentStephen Page
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 Received1998-01-28
Decision Date1998-04-27
Summary:summary

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