Product code OQB— Orthopedic
OptiMesh Multiplanar Expandable Interbody Fusion System
- Classification name
- Intervertebral Body Graft Containment Device
- Device class
- Class 2
- Regulation
- 21 CFR 888.3085
- Advisory panel
- Orthopedic
- Total cleared
- 4
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code OQB
FDA has cleared devices under product code OQB between 2020 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2025
- 2023
- 2020
Top applicants under product code OQB
Recent clearances under product code OQB
Data sourced from openFDA. This site is unofficial and independent of the FDA.