FDA 510(k)

Arco-SA Lumbar Cage System

K-Number: K182195 · 2018-11-09

Decision Date2018-11-09

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arco-SA Lumbar Cage System is a medical device manufactured by Neurostructures, Inc.. It received FDA 510(k) clearance on 2018-11-09 under approval number K182195. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arco-SA Lumbar Cage System?

Arco-SA Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Neurostructures, Inc.. The 510(k) number is K182195.

When was Arco-SA Lumbar Cage System approved by the FDA?

Arco-SA Lumbar Cage System received FDA 510(k) clearance on 2018-11-09, under approval number K182195.

What company makes Arco-SA Lumbar Cage System?

Arco-SA Lumbar Cage System is manufactured by Neurostructures, Inc..

What is the FDA product code for Arco-SA Lumbar Cage System?

The FDA product code for Arco-SA Lumbar Cage System is OVD.

Related Clinical Trials

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Other Devices by Neurostructures, Inc.

K153097Belvedere Lateral Plating System K171914Cortina Lumbar Cage System K171112Trifore(tm) Cervical Plating System K181590Neurostructures Cavetto® [MAX] Cervical Cage System K173082Arco-SA Lumbar Cage System K180431Cortina [MAX] Lumbar Cage System

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Related Devices (Code: OVD)

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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.