| Primary Device ID | M7405002628 |
| NIH Device Record Key | cadfd114-c951-48d3-bbef-80034ec6fc03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OptiMesh HA Nano Multiplanar Expandable Interbody Fusion System |
| Version Model Number | 32-01-37-4 |
| Catalog Number | 500-2628 |
| Company DUNS | 033014361 |
| Company Name | SPINEOLOGY INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com | |
| Phone | 651-256-8500 |
| info@spineology.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M7405002628 [Primary] |
| OQB | Intervertebral Body Graft Containment Device |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-29 |
| Device Publish Date | 2025-12-19 |
| M7405003440 | OptiMesh HA Nano, Large |
| M7405003032 | OptiMesh HA Nano, Medium |
| M7405002628 | OptiMesh HA Nano, Small |