OQBClass IIImplant
Intervertebral Body Graft Containment Device
Orthopedic · 21 CFR 888.3085
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.
MDR events28All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances4All time
Recent MDR events
28 adverse event reports on file
- OPTIMESHJan 9, 2026MalfunctionSpineology Inc.2135156-2026-00001
- OPTIMESHDec 22, 2025InjurySpineology Inc.2135156-2025-00012
- OPTIMESHNov 20, 2025InjurySpineology Inc.2135156-2025-00011
- OPTIMESHNov 12, 2025InjurySpineology Inc.2135156-2025-00010
- OPTIMESHOct 24, 2025InjurySpineology Inc.2135156-2025-00009
- OPTIMESHOct 1, 2025InjurySpineology Inc.2135156-2025-00006
- OPTIMESHOct 1, 2025InjurySpineology Inc.2135156-2025-00007
- OPTIMESHSep 12, 2025MalfunctionSpineology Inc.2135156-2025-00005
- OPTIMESHAug 15, 2025InjurySpineology Inc.2135156-2025-00003
- OPTIMESH DEPLOYABLE GRAFTING SYSTEMJun 30, 2025MalfunctionUnkMW5172097
Event type breakdown
Injury22
Malfunction6
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
4 clearances for this product code
- Spineology, Inc.Dec 15, 2025
K251302 · OptiMesh Multiplanar Expandable Interbody Fusion System
- Spineology, Inc.Nov 1, 2023
K230927 · OptiMesh Multiplanar Expandable Interbody Fusion System
- Spineology, Inc.Oct 18, 2023
K231781 · OptiMesh Multiplanar Expandable Interbody Fusion System
- Spineology, Inc.Sep 18, 2020
DEN200010 · Spineology Interbody Fusion System