FDA 510(k)

Lumfuse TP

K-Number: K173189 · 2018-06-08

Decision Date2018-06-08

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Lumfuse TP is a medical device manufactured by Precifit Medical, Ltd.. It received FDA 510(k) clearance on 2018-06-08 under approval number K173189. 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 Lumfuse TP?

Lumfuse TP is a medical device that received FDA 510(k) clearance on 2018-06-08. It is manufactured by Precifit Medical, Ltd.. The 510(k) number is K173189.

When was Lumfuse TP approved by the FDA?

Lumfuse TP received FDA 510(k) clearance on 2018-06-08, under approval number K173189.

What company makes Lumfuse TP?

Lumfuse TP is manufactured by Precifit Medical, Ltd..

What is the FDA product code for Lumfuse TP?

The FDA product code for Lumfuse TP is MAX.

Other Devices by Precifit Medical, Ltd.

K171630LumFuse-TP K163327Precifit Medical Kirschner Wires K172568Cervage

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.