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FDA 510(k)

OptiMesh Multiplanar Expandable Interbody Fusion System

K-Number: K231781 · 2023-10-18

ApplicantSpineology, Inc.
Decision Date2023-10-18
Product CodeOQB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OptiMesh Multiplanar Expandable Interbody Fusion System is a medical device manufactured by Spineology, Inc.. It received FDA 510(k) clearance on 2023-10-18 under approval number K231781. The device is classified under product code OQB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiMesh Multiplanar Expandable Interbody Fusion System?

OptiMesh Multiplanar Expandable Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-18. It is manufactured by Spineology, Inc.. The 510(k) number is K231781.

When was OptiMesh Multiplanar Expandable Interbody Fusion System approved by the FDA?

OptiMesh Multiplanar Expandable Interbody Fusion System received FDA 510(k) clearance on 2023-10-18, under approval number K231781.

What company makes OptiMesh Multiplanar Expandable Interbody Fusion System?

OptiMesh Multiplanar Expandable Interbody Fusion System is manufactured by Spineology, Inc..

What is the FDA product code for OptiMesh Multiplanar Expandable Interbody Fusion System?

The FDA product code for OptiMesh Multiplanar Expandable Interbody Fusion System is OQB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT07017634 Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease RECRUITING

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024)

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

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Related Devices (Code: OQB)

DEN200010Spineology Interbody Fusion SystemSpineology, Inc. K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, 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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