Cavetto [MAX] Cervical Cage System

Intervertebral Fusion Device With Bone Graft, Cervical

NeuroStructures, Inc.

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

Pre-market Notification Details

Device IDK201769
510k NumberK201769
Device Name:Cavetto [MAX] Cervical Cage System
ClassificationIntervertebral Fusion Device With Bone Graft, 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 CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-29
Decision Date2020-09-03

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