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Neurostructures, Inc.

FDA Regulatory Profile

Neurostructures, Inc. has 0 FDA recalls, 3 inspections, 19 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 10, 2020 · NAI
Latest 510(k)
Oct 2, 2020

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances19Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 10, 2020Dallas, TXDevicesNo Action Indicated (NAI)3008853203
Aug 12, 2014Dallas, TXDevicesNo Action Indicated (NAI)3008853203
May 12, 2014Dallas, TXDevicesVoluntary Action Indicated (VAI)3008853203

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K202190Oculus-SA Lumbar Cage SystemOct 2, 2020
K200115Cavetto-SA Cervical Cage SystemSep 24, 2020
K201769Cavetto [MAX] Cervical Cage SystemSep 3, 2020
K200927Transept Cervical Plate SystemJul 24, 2020
K192248Cortina™ [MAX] Lumbar Cage SystemNov 25, 2019
K182195Arco™-SA Lumbar Cage SystemNov 9, 2018
K181590Neurostructures Cavetto® [MAX] Cervical Cage SystemNov 8, 2018
K173082Arco™-SA Lumbar Cage SystemMar 29, 2018
K180431Cortina [MAX] Lumbar Cage SystemMar 22, 2018
K172320Neurostructures Cavetto® Cervical Cage SystemFeb 26, 2018
K173077Cavetto-SA Cervical Cage SystemFeb 23, 2018
K171914Cortina™ Lumbar Cage SystemOct 25, 2017
K171112Trifore(tm) Cervical Plating SystemJun 8, 2017
K153097Belvedere™ Lateral Plating SystemJul 15, 2016
K143230Palladian Lumbar Pedicle Screw SystemFeb 25, 2015
K142060TRANSOM ANTERIOR CERVICAL PLATENov 18, 2014
K131374TEMPUS(TM) CERVICAL PLATE SYSTEMAug 23, 2013
K121551RESOLUTE FACET SCREW SYSTEMOct 23, 2012
K120515TEMPUS CERVICAL PLATE SYSTEMMay 23, 2012

FDA data resources