FDA 510(k)

PROW FUSION-V

K-Number: K153786 · 2016-07-11

Decision Date2016-07-11

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PROW FUSION-V is a medical device manufactured by Nlt Spine, Ltd.. It received FDA 510(k) clearance on 2016-07-11 under approval number K153786. 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 PROW FUSION-V?

PROW FUSION-V is a medical device that received FDA 510(k) clearance on 2016-07-11. It is manufactured by Nlt Spine, Ltd.. The 510(k) number is K153786.

When was PROW FUSION-V approved by the FDA?

PROW FUSION-V received FDA 510(k) clearance on 2016-07-11, under approval number K153786.

What company makes PROW FUSION-V?

PROW FUSION-V is manufactured by Nlt Spine, Ltd..

What is the FDA product code for PROW FUSION-V?

The FDA product code for PROW FUSION-V is MAX.

Other Devices by Nlt Spine, Ltd.

K153665PROW FUSION-L

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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.