FDA 510(k)

Neo Cage System

K-Number: K191796 · 2019-12-13

Decision Date2019-12-13

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Neo Cage System is a medical device manufactured by Neo Medical SA. It received FDA 510(k) clearance on 2019-12-13 under approval number K191796. 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 Neo Cage System?

Neo Cage System is a medical device that received FDA 510(k) clearance on 2019-12-13. It is manufactured by Neo Medical SA. The 510(k) number is K191796.

When was Neo Cage System approved by the FDA?

Neo Cage System received FDA 510(k) clearance on 2019-12-13, under approval number K191796.

What company makes Neo Cage System?

Neo Cage System is manufactured by Neo Medical SA.

What is the FDA product code for Neo Cage System?

The FDA product code for Neo Cage System is MAX.

Other Devices by Neo Medical SA

K171582NEO Pedicle Screw System K181048Neo Cage System TM K212489BonOs Inject Bone Cement; NEO Pedicle Screw System K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System K243693NEO Pedicle Screw System

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

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