FDA 510(k)

LumiVy Lumbar IBF System

K-Number: K212930 · 2022-02-16

Decision Date2022-02-16

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LumiVy Lumbar IBF System is a medical device manufactured by Vy Spine, LLC. It received FDA 510(k) clearance on 2022-02-16 under approval number K212930. 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 LumiVy Lumbar IBF System?

LumiVy Lumbar IBF System is a medical device that received FDA 510(k) clearance on 2022-02-16. It is manufactured by Vy Spine, LLC. The 510(k) number is K212930.

When was LumiVy Lumbar IBF System approved by the FDA?

LumiVy Lumbar IBF System received FDA 510(k) clearance on 2022-02-16, under approval number K212930.

What company makes LumiVy Lumbar IBF System?

LumiVy Lumbar IBF System is manufactured by Vy Spine, LLC.

What is the FDA product code for LumiVy Lumbar IBF System?

The FDA product code for LumiVy Lumbar IBF System 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

View on FDA Database →

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