FDA 510(k)

Arco-SA Lumbar Cage System

K-Number: K173082 · 2018-03-29

Decision Date2018-03-29

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 2018-03-29 under approval number K173082. 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 2018-03-29. It is manufactured by Neurostructures, Inc.. The 510(k) number is K173082.

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

Arco-SA Lumbar Cage System received FDA 510(k) clearance on 2018-03-29, under approval number K173082.

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 K182195Arco-SA Lumbar Cage System K181590Neurostructures Cavetto® [MAX] Cervical Cage System K180431Cortina [MAX] Lumbar Cage System

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Related Devices (Code: OVD)

K162680SOVEREIGN® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162351SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation K161993Leva® Anterior Interbody SystemSpine Wave, Inc. K161379ELSA SpacersGlobus Medical, Inc. K161173Avenue® T TLIF CageLdr Spine USA, Inc. K161129PILLAR SA PTCOrthofix, Inc.

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.