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 IDK200115
510k NumberK200115
Device Name:Cavetto-SA Cervical Cage System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant NeuroStructures, Inc. 199 Technology Drive, Suite 110 Irvine,  CA  92618
ContactMoti Altarac
CorrespondentNathan Wright
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-09-24

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