FDA 510(k)

CoreLink F3D Lateral System

K-Number: K183239 · 2018-12-19

Decision Date2018-12-19

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

CoreLink F3D Lateral System is a medical device manufactured by Corelink, LLC. It received FDA 510(k) clearance on 2018-12-19 under approval number K183239. 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 CoreLink F3D Lateral System?

CoreLink F3D Lateral System is a medical device that received FDA 510(k) clearance on 2018-12-19. It is manufactured by Corelink, LLC. The 510(k) number is K183239.

When was CoreLink F3D Lateral System approved by the FDA?

CoreLink F3D Lateral System received FDA 510(k) clearance on 2018-12-19, under approval number K183239.

What company makes CoreLink F3D Lateral System?

CoreLink F3D Lateral System is manufactured by Corelink, LLC.

What is the FDA product code for CoreLink F3D Lateral System?

The FDA product code for CoreLink F3D Lateral System is MAX.

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Other Devices by Corelink, LLC

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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

View on FDA Database →

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