BIOROC EZ SUTURE BONE FASTENER

Fastener, Fixation, Biodegradable, Soft Tissue

INNOVASIVE DEVICES, INC.

The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Bioroc Ez Suture Bone Fastener.

Pre-market Notification Details

Device IDK973381
510k NumberK973381
Device Name:BIOROC EZ SUTURE BONE FASTENER
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactStephen M Page
CorrespondentStephen M Page
INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-08
Decision Date1998-02-18
Summary:summary

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