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FDA 510(k)

TruLift Lateral Expandable Spacer System & Lateral Plate System

K-Number: K221806 · 2022-12-05

ApplicantLife Spine, Inc.
Decision Date2022-12-05
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TruLift Lateral Expandable Spacer System & Lateral Plate System is a medical device manufactured by Life Spine, Inc.. It received FDA 510(k) clearance on 2022-12-05 under approval number K221806. 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 TruLift Lateral Expandable Spacer System & Lateral Plate System?

TruLift Lateral Expandable Spacer System & Lateral Plate System is a medical device that received FDA 510(k) clearance on 2022-12-05. It is manufactured by Life Spine, Inc.. The 510(k) number is K221806.

When was TruLift Lateral Expandable Spacer System & Lateral Plate System approved by the FDA?

TruLift Lateral Expandable Spacer System & Lateral Plate System received FDA 510(k) clearance on 2022-12-05, under approval number K221806.

What company makes TruLift Lateral Expandable Spacer System & Lateral Plate System?

TruLift Lateral Expandable Spacer System & Lateral Plate System is manufactured by Life Spine, Inc..

What is the FDA product code for TruLift Lateral Expandable Spacer System & Lateral Plate System?

The FDA product code for TruLift Lateral Expandable Spacer System & Lateral Plate 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

View on FDA Database →

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

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