| Primary Device ID | 10840642162110 |
| NIH Device Record Key | 450ec1c7-64ac-4862-8a55-b434ea21544a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Stronghold® T 3D Titanium Interbody Device System |
| Version Model Number | SW19106-3016 |
| Catalog Number | SW19106-3016 |
| Company DUNS | 067789763 |
| Company Name | Spine Wave, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com | |
| Phone | 203-944-9494 |
| GUDID@spinewave.com |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Length | 30 Millimeter |
| Height | 16 Millimeter |
| Angle | 6 degree |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10840642162110 [Primary] |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-05 |
| Device Publish Date | 2021-07-28 |
| 10840642162110 | Curved Titanium Cage - Lordotic 30 mm x 16 mm |
| 10840642162103 | Curved Titanium Cage - Lordotic 30 mm x 15 mm |
| 10840642162097 | Curved Titanium Cage - Lordotic 30 mm x 14 mm |
| 10840642162080 | Curved Titanium Cage - Lordotic 30 mm x 13 mm |
| 10840642162073 | Curved Titanium Cage - Lordotic 30 mm x 12 mm |
| 10840642162066 | Curved Titanium Cage - Lordotic 30 mm x 11 mm |
| 10840642162059 | Curved Titanium Cage - Lordotic 30 mm x 10 mm |
| 10840642162042 | Curved Titanium Cage - Lordotic 30 mm x 9 mm |
| 10840642162035 | Curved Titanium Cage - Lordotic 30 mm x 8 mm |