INNOVASIVE DEVICES ROTATOR CUFF 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 Devices Rotator Cuff Fastener.

Pre-market Notification Details

Device IDK951565
510k NumberK951565
Device Name:INNOVASIVE DEVICES ROTATOR CUFF FASTENER
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton,  MA  01748
ContactEriv Bannon
CorrespondentEriv Bannon
INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton,  MA  01748
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-04
Decision Date1995-09-08

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