OptiMesh Multiplanar Expandable Interbody Fusion System

FDA 510(k) K251302 · Spineology, Inc.

Substantially Equivalent

510(k) numberK251302

Submission

Device name
OptiMesh Multiplanar Expandable Interbody Fusion System
Applicant
Spineology, Inc.
Saint Paul, MN, US
Received
April 28, 2025
Decision date
December 15, 2025
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
K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional Spineology, Inc.11/01/2023SE
K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Special Spineology, Inc.10/18/2023SE

More from Spineology, Inc.

510(k)DeviceDecision
K251943Spineology Navigation InstrumentsOLO · Special 12/04/2025SE
K230927OptiMesh Multiplanar Expandable Interbody Fusion SystemOQB · Traditional 11/01/2023SE
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 (K251302) received a 510(k) decision of Substantially Equivalent on December 15, 2025, 231 days after the submission was received.

What is the product code of K251302?

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