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FDA 510(k)

Duo Lumbar Interbody Fusion Device

K-Number: K190055 · 2019-03-07

ApplicantSpineology, Inc.
Decision Date2019-03-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Duo Lumbar Interbody Fusion Device is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2019-03-07 under approval number K190055. 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 Duo Lumbar Interbody Fusion Device?

Duo Lumbar Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Spineology, Inc.. The 510(k) number is K190055.

When was Duo Lumbar Interbody Fusion Device approved by the FDA?

Duo Lumbar Interbody Fusion Device received FDA 510(k) clearance on 2019-03-07, under approval number K190055.

What company makes Duo Lumbar Interbody Fusion Device?

Duo Lumbar Interbody Fusion Device is manufactured by Spineology, Inc..

What is the FDA product code for Duo Lumbar Interbody Fusion Device?

The FDA product code for Duo Lumbar Interbody 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 NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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 Spineology, Inc.

K160074Rampart D Lumbar Interbody Fusion Device K161694Threshold™ Pedicular Fixation System K160906Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation System K153323Palisade Pedicular Fixation System K153082Rampart A Lumbar Interbody Fusion Device

View all 33 devices →

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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