FDA 510(k)

VertebraLINK Fusion Platform

K-Number: K162693 · 2017-03-29

Decision Date2017-03-29

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VertebraLINK Fusion Platform is a medical device manufactured by Facetlink Dba Linkspine. It received FDA 510(k) clearance on 2017-03-29 under approval number K162693. 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 VertebraLINK Fusion Platform?

VertebraLINK Fusion Platform is a medical device that received FDA 510(k) clearance on 2017-03-29. It is manufactured by Facetlink Dba Linkspine. The 510(k) number is K162693.

When was VertebraLINK Fusion Platform approved by the FDA?

VertebraLINK Fusion Platform received FDA 510(k) clearance on 2017-03-29, under approval number K162693.

What company makes VertebraLINK Fusion Platform?

VertebraLINK Fusion Platform is manufactured by Facetlink Dba Linkspine.

What is the FDA product code for VertebraLINK Fusion Platform?

The FDA product code for VertebraLINK Fusion Platform is MAX.

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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

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