FDA 510(k)

Cortina [MAX] Lumbar Cage System

K-Number: K192248 · 2019-11-25

Decision Date2019-11-25

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Cortina [MAX] Lumbar Cage System is a medical device manufactured by Neurostructures, Inc.. It received FDA 510(k) clearance on 2019-11-25 under approval number K192248. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cortina [MAX] Lumbar Cage System?

Cortina [MAX] Lumbar Cage System is a medical device that received FDA 510(k) clearance on 2019-11-25. It is manufactured by Neurostructures, Inc.. The 510(k) number is K192248.

When was Cortina [MAX] Lumbar Cage System approved by the FDA?

Cortina [MAX] Lumbar Cage System received FDA 510(k) clearance on 2019-11-25, under approval number K192248.

What company makes Cortina [MAX] Lumbar Cage System?

Cortina [MAX] Lumbar Cage System is manufactured by Neurostructures, Inc..

What is the FDA product code for Cortina [MAX] Lumbar Cage System?

The FDA product code for Cortina [MAX] Lumbar Cage System is MAX.

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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 K173082Arco-SA Lumbar Cage System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, 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.