INNOVASIVE 3.5MM METAL ROC XS 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 3.5mm Metal Roc Xs Suture Bone Fastener.

Pre-market Notification Details

Device IDK981193
510k NumberK981193
Device Name:INNOVASIVE 3.5MM METAL ROC XS SUTURE BONE FASTENER
ClassificationFastener, Fixation, Nondegradable, 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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-02
Decision Date1998-06-16
Summary:summary

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