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FDA 510(k)

FortiCore®

K-Number: K171312 · 2018-01-22

ApplicantNanovis, LLC
Decision Date2018-01-22
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FortiCore® is a medical device manufactured by Nanovis, LLC. It received FDA 510(k) clearance on 2018-01-22 under approval number K171312. 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 FortiCore®?

FortiCore® is a medical device that received FDA 510(k) clearance on 2018-01-22. It is manufactured by Nanovis, LLC. The 510(k) number is K171312.

When was FortiCore® approved by the FDA?

FortiCore® received FDA 510(k) clearance on 2018-01-22, under approval number K171312.

What company makes FortiCore®?

FortiCore® is manufactured by Nanovis, LLC.

What is the FDA product code for FortiCore®?

The FDA product code for FortiCore® is MAX.

Other Devices by Nanovis, 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.

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