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FDA 510(k)

Neurostructures Cavetto® [MAX] Cervical Cage System

K-Number: K181590 · 2018-11-08

ApplicantNeurostructures, Inc.
Decision Date2018-11-08
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Neurostructures Cavetto® [MAX] Cervical Cage System is a medical device manufactured by Neurostructures, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval number K181590. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neurostructures Cavetto® [MAX] Cervical Cage System?

Neurostructures Cavetto® [MAX] Cervical Cage System is a medical device that received FDA 510(k) clearance on 2018-11-08. It is manufactured by Neurostructures, Inc.. The 510(k) number is K181590.

When was Neurostructures Cavetto® [MAX] Cervical Cage System approved by the FDA?

Neurostructures Cavetto® [MAX] Cervical Cage System received FDA 510(k) clearance on 2018-11-08, under approval number K181590.

What company makes Neurostructures Cavetto® [MAX] Cervical Cage System?

Neurostructures Cavetto® [MAX] Cervical Cage System is manufactured by Neurostructures, Inc..

What is the FDA product code for Neurostructures Cavetto® [MAX] Cervical Cage System?

The FDA product code for Neurostructures Cavetto® [MAX] Cervical Cage System is ODP.

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Other Devices by Neurostructures, Inc.

K153097Belvedere™ Lateral Plating System K171914Cortina™ Lumbar Cage System K171112Trifore(tm) Cervical Plating System K182195Arco™-SA Lumbar Cage System K173082Arco™-SA Lumbar Cage System K180431Cortina [MAX] Lumbar Cage System

View all 13 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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