INNOVASIVE LINX BT 10MM 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 Linx Bt 10mm Ligament Fastener.

Pre-market Notification Details

Device IDK974049
510k NumberK974049
Device Name:INNOVASIVE LINX BT 10MM 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  
Subsequent Product CodeHRX
Subsequent Product CodeHWC
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-24
Decision Date1998-02-18
Summary:summary

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