| Primary Device ID | 10888857462700 | 
| NIH Device Record Key | 835ab56e-424e-424b-aa2f-6d4135c6e845 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SAHARA™ Stabilization System | 
| Version Model Number | 7908-2D225012L10-G2 | 
| Catalog Number | 7908-2D225012L10-G2 | 
| Company DUNS | 146060863 | 
| Company Name | K2M, 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 | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | |
| Phone | +1(571)919-2000 | 
| mark.zellers@stryker.com | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Width | 22 Millimeter | 
| Height | 12 Millimeter | 
| Angle | 10 degree | 
| Length | 50 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 10888857462700 [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 | 2020-10-01 | 
| Device Publish Date | 2020-09-23 | 
| 10888857381728 | Footprint Trial, 30x40 mm, Tapered | 
| 10888857381711 | Footprint Trial, 28x36 mm, Tapered | 
| 10888857381704 | Footprint Trial, 24x30 mm, Tapered | 
| 10888857213814 | Expandable ALIF, Size 30x40x20 mm, 5° | 
| 10888857213807 | Expandable ALIF, Size 30x40x20 mm, 15° | 
| 10888857213791 | Expandable ALIF, Size 30x40x20 mm, 10° | 
| 10888857213784 | Expandable ALIF, Size 28x36x20 mm, 5° | 
| 10888857213777 | Expandable ALIF, Size 28x36x20 mm, 15° | 
| 10888857213760 | Expandable ALIF, Size 28x36x20 mm, 10° | 
| 10888857213753 | Expandable ALIF, Size 24x30x20 mm, 5° | 
| 10888857213746 | Expandable ALIF, Size 24x30x20 mm, 15° | 
| 10888857213739 | Expandable ALIF, Size 24x30x20 mm, 10° | 
| 10888857213722 | Expandable ALIF, Size 30x40x19 mm, 5° | 
| 10888857213715 | Expandable ALIF, Size 30x40x19 mm, 15° | 
| 10888857213708 | Expandable ALIF, Size 30x40x19 mm, 10° | 
| 10888857213692 | Expandable ALIF, Size 28x36x19 mm, 5° | 
| 10888857213685 | Expandable ALIF, Size 28x36x19 mm, 15° | 
| 10888857213678 | Expandable ALIF, Size 28x36x19 mm, 10° | 
| 10888857213661 | Expandable ALIF, Size 24x30x19 mm, 5° | 
| 10888857213654 | Expandable ALIF, Size 24x30x19 mm, 15° | 
| 10888857213647 | Expandable ALIF, Size 24x30x19 mm, 10° | 
| 10888857213630 | Expandable ALIF, Size 30x40x18 mm, 5° | 
| 10888857213623 | Expandable ALIF, Size 30x40x18 mm, 15° | 
| 10888857213616 | Expandable ALIF, Size 30x40x18 mm, 10° | 
| 10888857213609 | Expandable ALIF, Size 28x36x18 mm, 5° | 
| 10888857213593 | Expandable ALIF, Size 28x36x18 mm, 15° | 
| 10888857213586 | Expandable ALIF, Size 28x36x18 mm, 10° | 
| 10888857213579 | Expandable ALIF, Size 24x30x18 mm, 5° | 
| 10888857213562 | Expandable ALIF, Size 24x30x18 mm, 15° | 
| 10888857213555 | Expandable ALIF, Size 24x30x18 mm, 10° | 
| 10888857213548 | Expandable ALIF Size 30x40x17 mm, 5° | 
| 10888857213531 | Expandable ALIF Size 30x40x17 mm, 15° | 
| 10888857213524 | Expandable ALIF Size 30x40x17 mm, 10° | 
| 10888857213517 | Expandable ALIF Size 28x36x17 mm, 5° | 
| 10888857213500 | Expandable ALIF Size 28x36x17 mm, 15° | 
| 10888857213494 | Expandable ALIF Size 28x36x17 mm, 10° | 
| 10888857213487 | Expandable ALIF Size 24x30x17 mm, 5° | 
| 10888857213470 | Expandable ALIF Size 24x30x17 mm, 15° | 
| 10888857213463 | Expandable ALIF Size 24x30x17 mm, 10° | 
| 10888857213456 | Expandable ALIF, Size 30x40x16 mm, 5° | 
| 10888857213449 | Expandable ALIF Size 30x40x16 mm, 15° | 
| 10888857213432 | Expandable ALIF, Size 30x40x16 mm, 10° | 
| 10888857213425 | Expandable ALIF, Size 28x36x16 mm, 5° | 
| 10888857213418 | Expandable ALIF Size 28x36x16 mm, 15° | 
| 10888857213401 | Expandable ALIF, Size 28x36x16 mm, 10° | 
| 10888857213395 | Expandable ALIF, Size 24x30x16 mm, 5° | 
| 10888857213388 | Expandable ALIF Size 24x30x16 mm, 15° | 
| 10888857213371 | Expandable ALIF, Size 24x30x16 mm, 10° | 
| 10888857213364 | Expandable ALIF Size 30x40x15 mm, 5° | 
| 10888857213357 | Expandable ALIF Size 30x40x15 mm, 10° |