Cavetto-SA Cervical Cage System

Intervertebral Fusion Device With Integrated Fixation, Cervical

NeuroStructures, Inc.

The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Cavetto-sa Cervical Cage System.

Pre-market Notification Details

Device IDK173077
510k NumberK173077
Device Name:Cavetto-SA Cervical Cage System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant NeuroStructures, Inc. 16 Technology Drive Suite 165 Irvine,  CA  92618
ContactKathleen Wong
CorrespondentKenneth C. Maxwell Ii
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2018-02-23
Summary:summary

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