FDA 510(k)

LumFuse-TP

K-Number: K171630 · 2017-07-25

Decision Date2017-07-25

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 2017-07-25 under approval number K171630. 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 2017-07-25. It is manufactured by Precifit Medical, Ltd.. The 510(k) number is K171630.

When was LumFuse-TP approved by the FDA?

LumFuse-TP received FDA 510(k) clearance on 2017-07-25, under approval number K171630.

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.

K163327Precifit Medical Kirschner Wires K173189Lumfuse TP 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.