OptiMesh Multiplanar Expandable Interbody Fusion System

FDA 510(k) K230927 · Spineology, Inc.

Substantially Equivalent

510(k) numberK230927

Submission

Device name
OptiMesh Multiplanar Expandable Interbody Fusion System
Applicant
Spineology, Inc.
Saint Paul, MN, US
Received
April 3, 2023
Decision date
November 1, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OQB – Intervertebral Body Graft Containment Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3085
Specialty
Orthopedic
Implant
Yes

An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

Other 510(k)s with product code OQB

510(k)DeviceApplicantDecision
K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional Spineology, Inc.12/15/2025SE
K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special Spineology, Inc.10/18/2023SE

More from Spineology, Inc.

510(k)DeviceDecision
K251302OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional 12/15/2025SE
K251943Spineology Navigation InstrumentsOLO · Special 12/04/2025SE
K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special 10/18/2023SE
K213876Spineology Navigation InstrumentsOLO · Traditional 08/05/2022SE
K210155Duo Expandable Interbody Fusion SystemMAX · Special 02/19/2021SE
K192047Rampart™ One Lumbar Interbody Fusion SystemOVD · Special 08/23/2019SE
K191091Rampart One Lumbar Interbody Fusion SystemOVD · Special 05/23/2019SE
K190055Duo Lumbar Interbody Fusion DeviceMAX · Special 03/07/2019SE
K182322Duo Lumbar Interbody Fusion DeviceMAX · Traditional 10/24/2018SE
K182345Spineology Navigation InstrumentsOLO · Special 09/21/2018SE

Questions and answers

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

OptiMesh Multiplanar Expandable Interbody Fusion System (K230927) received a 510(k) decision of Substantially Equivalent on November 1, 2023, 212 days after the submission was received.

What is the product code of K230927?

The FDA product code is OQB – Intervertebral Body Graft Containment Device, a Class II (moderate risk) device regulated under 21 CFR 888.3085.