INNOVASIVE 2.3MM ROC EZ SUTURE BONE 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 2.3mm Roc Ez Suture Bone Fastener.

Pre-market Notification Details

Device IDK972356
510k NumberK972356
Device Name:INNOVASIVE 2.3MM ROC EZ SUTURE BONE 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 Received1997-06-25
Decision Date1997-08-26
Summary:summary

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