FDA 510(k)

Hexanium PLIF

K-Number: K223251 · 2022-12-16

Decision Date2022-12-16

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Hexanium PLIF is a medical device manufactured by Spinevision, S.A.S.. It received FDA 510(k) clearance on 2022-12-16 under approval number K223251. 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 PLIF?

Hexanium PLIF is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Spinevision, S.A.S.. The 510(k) number is K223251.

When was Hexanium PLIF approved by the FDA?

Hexanium PLIF received FDA 510(k) clearance on 2022-12-16, under approval number K223251.

What company makes Hexanium PLIF?

Hexanium PLIF is manufactured by Spinevision, S.A.S..

What is the FDA product code for Hexanium PLIF?

The FDA product code for Hexanium PLIF is MAX.

Other Devices by Spinevision, S.A.S.

K180437Hexanium® TLIF K193000Hexanium® ACIF K210359Hexanium TLIF 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.