| Primary Device ID | 10840642162103 | 
| NIH Device Record Key | ba221e2f-a978-460f-b0b3-59e6f91c1c64 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Stronghold® T 3D Titanium Interbody Device System | 
| Version Model Number | SW19106-3015 | 
| Catalog Number | SW19106-3015 | 
| 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 | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Length | 30 Millimeter | 
| Height | 15 Millimeter | 
| Angle | 6 degree | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10840642162103 [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 |