510(k) K251302
K251302 is an FDA 510(k) premarket notification submitted by Spineology, Inc. for the device "OptiMesh Multiplanar Expandable Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on December 15, 2025. The device falls under product code OQB (Intervertebral Body Graft Containment Device), a Class II device regulated under 21 CFR 888.3085. Spineology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 2025
- Date Received
- April 28, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Body Graft Containment Device
- Device Class
- Class II
- Regulation Number
- 888.3085
- Review Panel
- OR
- Submission Type
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.