FDA 510(k)

Hexanium TLIF

K-Number: K210359 · 2021-03-10

Decision Date2021-03-10

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 2021-03-10 under approval number K210359. 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 2021-03-10. It is manufactured by Spinevision, S.A.S.. The 510(k) number is K210359.

When was Hexanium TLIF approved by the FDA?

Hexanium TLIF received FDA 510(k) clearance on 2021-03-10, under approval number K210359.

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.

K180437Hexanium® TLIF K193000Hexanium® ACIF 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.