INNOVASIVE SUTURE BONE FASTENER WITH SUTURE

Staple, Fixation, Bone

INNOVASIVE DEVICES, INC.

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

Pre-market Notification Details

Device IDK935321
510k NumberK935321
Device Name:INNOVASIVE SUTURE BONE FASTENER WITH SUTURE
ClassificationStaple, Fixation, Bone
Applicant INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton,  MA  01748
ContactEric Bannon
CorrespondentEric Bannon
INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton,  MA  01748
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-11-04
Decision Date1994-10-19

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