ACL CLIP-IN

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 Acl Clip-in.

Pre-market Notification Details

Device IDK973323
510k NumberK973323
Device Name:ACL CLIP-IN
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactEric Bannon
CorrespondentEric Bannon
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 Received1997-09-04
Decision Date1997-12-01
Summary:summary

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