FDA 510(k)

Life Spine Resolute Threaded Cage System

K-Number: K181625 · 2018-12-11

Decision Date2018-12-11

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Life Spine Resolute Threaded Cage System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2018-12-11 under approval number K181625. 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 Life Spine Resolute Threaded Cage System?

Life Spine Resolute Threaded Cage System is a medical device that received FDA 510(k) clearance on 2018-12-11. It is manufactured by Life Spine, Inc.. The 510(k) number is K181625.

When was Life Spine Resolute Threaded Cage System approved by the FDA?

Life Spine Resolute Threaded Cage System received FDA 510(k) clearance on 2018-12-11, under approval number K181625.

What company makes Life Spine Resolute Threaded Cage System?

Life Spine Resolute Threaded Cage System is manufactured by Life Spine, Inc..

What is the FDA product code for Life Spine Resolute Threaded Cage System?

The FDA product code for Life Spine Resolute Threaded Cage System is MAX.

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Other Devices by Life Spine, Inc.

K161127The Small PLATEAU (PLATEAU-C) Spacer System K160066Pro-Link® Stand-Alone Cervical Spacer System K161037Tarsa-Link Stand-Alone Wedge Fixation System K153065The Hammertoe Correction System K153400ProLift Expandable System K172973Life Spine Foot and Ankle Plating System

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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

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