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FDA 510(k)

DualX Lumbar Intervertebral Body Fusion Device

K-Number: K192434 · 2019-10-15

ApplicantAmplify Surgical, Inc.
Decision Date2019-10-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DualX Lumbar Intervertebral Body Fusion Device is a medical device manufactured by Amplify Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under approval number K192434. 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 DualX Lumbar Intervertebral Body Fusion Device?

DualX Lumbar Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2019-10-15. It is manufactured by Amplify Surgical, Inc.. The 510(k) number is K192434.

When was DualX Lumbar Intervertebral Body Fusion Device approved by the FDA?

DualX Lumbar Intervertebral Body Fusion Device received FDA 510(k) clearance on 2019-10-15, under approval number K192434.

What company makes DualX Lumbar Intervertebral Body Fusion Device?

DualX Lumbar Intervertebral Body Fusion Device is manufactured by Amplify Surgical, Inc..

What is the FDA product code for DualX Lumbar Intervertebral Body Fusion Device?

The FDA product code for DualX Lumbar Intervertebral Body Fusion Device is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07610850 Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation NOT_YET_RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT07277803 Device-Based vs Manual Sensory Training in Low Back Pain NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Amplify Surgical, Inc.

K211740DualX K222203DualXSLIM(R) T/PLIF

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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