FDA.reportPublic FDA data

Neurostructures

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088532033008853203NeuroStructures, Inc.1N2020-04-25199 Technology Drive Suite 110 Irvine CA US 92618

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841508101611Cabo™ - 5 LEVEL PLATE 90mm8003526103customerservice@neurostructures.com
00841508101628Cabo™ - 5 LEVEL PLATE 95mm8003526103customerservice@neurostructures.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1266391503967990K180431Cortina [MAX] Lumbar Cage SystemMAX2018-03-22
1266391522416699K173082Arco™-SA Lumbar Cage SystemOVD2018-03-29
1266391332395095K173077Cavetto-SA Cervical Cage SystemOVE2018-02-23
1266391852476286K172320Neurostructures Cavetto® Cervical Cage SystemODP2018-02-26
1266391846878120K171914Cortina™ Lumbar Cage SystemMAX2017-10-25
1266391727142196K171112Trifore(tm) Cervical Plating SystemKWQ2017-06-08
1266391294761837K153097Belvedere™ Lateral Plating SystemKWQ2016-07-15
1266391258391928K152259InFill Interbody Fusion DeviceMAX2015-11-19
1266392000579407K151184InFill Interbody Fusion DevicesMAX2015-07-14
1266391363277474K150206InFill Interbody Fusion DevicesMAX2015-04-03
1266391470024875K143488InFill Graft Delivery SystemFMF2014-12-17
1266391184263593K143230Palladian Lumbar Pedicle Screw SystemNKB2015-02-25
1266391745066546K142060TRANSOM ANTERIOR CERVICAL PLATEKWQ2014-11-18
1266391631503968K142041POROSTEON PHUSION METAL CERVICAL CAGEODP2014-12-19
1266391446299956K141282PGS 5.5 MM CANNULATED PEDICLE SCREWNKB2014-12-02
1266392011403177K140066INFILL CERVICALODP2014-05-05
1266391241612452K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60MAX2014-03-31
1266391118841045K131374TEMPUS(TM) CERVICAL PLATE SYSTEMKWQ2013-08-23
1266391578858093K124012INFILL OBLIQUE TLIF DEVICEMAX2013-06-04
1266391093554750K121733INFILL INTERVERTEBRAL BODY FUSION DEVICEMAX2012-07-13
1266391710000011K121551RESOLUTE FACET SCREW SYSTEMMRW2012-10-23
1266391582182743K121476INFILL GRAFT DELIVERY SYSTEMFMF2012-08-29
1266391085702934K120515TEMPUS CERVICAL PLATE SYSTEMKWQ2012-05-23
1266391266982751K111632INFILL GRAFT DELIVERY SYSTEMFMF2011-08-11
1266391216023960K103729INFILL INTERVERTEBRAL BODY FUSION DEVICEMAX2011-04-18
1266391684767319

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MAX92018-03-22
KWQ52017-06-08
ODP32018-02-26
FMF32014-12-17
NKB22015-02-25
OVD12018-03-29
OVE12018-02-23
MRW12012-10-23

PMN#

GUDID#

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