SUTURELESS ANCHOR

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 Sutureless Anchor.

Pre-market Notification Details

Device IDK984490
510k NumberK984490
Device Name:SUTURELESS ANCHOR
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 734 FOREST ST. Marlborough,  MA  01752
ContactKathleen Morahan
CorrespondentKathleen Morahan
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 Received1998-12-17
Decision Date1999-03-01
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.