FDA 510(k)

Hexanium® TLIF

K-Number: K180437 · 2018-05-04

Decision Date2018-05-04

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hexanium® TLIF is a medical device manufactured by Spinevision, S.A.S.. It received FDA 510(k) clearance on 2018-05-04 under approval number K180437. 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 Hexanium® TLIF?

Hexanium® TLIF is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by Spinevision, S.A.S.. The 510(k) number is K180437.

When was Hexanium® TLIF approved by the FDA?

Hexanium® TLIF received FDA 510(k) clearance on 2018-05-04, under approval number K180437.

What company makes Hexanium® TLIF?

Hexanium® TLIF is manufactured by Spinevision, S.A.S..

What is the FDA product code for Hexanium® TLIF?

The FDA product code for Hexanium® TLIF is MAX.

Other Devices by Spinevision, S.A.S.

K193000Hexanium® ACIF K210359Hexanium TLIF K223251Hexanium PLIF K221578Hexanium ACIF

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.