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OQB

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Intervertebral Body Graft Containment Device
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3085
Medical specialty
Orthopedic
Flags
Implant
FDA 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.
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RecordFirmDate
OptiMesh Multiplanar Expandable Interbody Fusion System (K251302)Spineology, Inc.2025-12-15
OptiMesh Multiplanar Expandable Interbody Fusion System (K230927)Spineology, Inc.2023-11-01
OptiMesh Multiplanar Expandable Interbody Fusion System (K231781)Spineology, Inc.2023-10-18
Spineology Interbody Fusion System (DEN200010)Spineology, Inc.2020-09-18

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Every clearance here is in the API, with alerts when new ones post.