| Primary Device ID | 10888857394148 |
| NIH Device Record Key | 31aa1cb5-36d5-41a9-8bae-f52596022f8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALEUTIAN Interbody Systems |
| Version Model Number | SP-2463-04 |
| Catalog Number | SP-2463-04 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.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 | |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857394148 [Primary] |
| ODP | Intervertebral fusion device with bone graft, cervical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
[10888857394148]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-01-30 |
| 10888857394162 | Parallel Angled Trial, Size 20x60x7 mm |
| 10888857394155 | Parallel Angled Trial, Size 20x60x6 mm |
| 10888857394148 | Parallel Angled Trial, Size 20x60x5 mm |
| 10888857394131 | Lordotic Angled Trial, Size 20x60x7 mm, 8° |
| 10888857394124 | Lordotic Angled Trial, Size 20x60x6 mm, 8° |
| 10888857394117 | Lordotic Angled Trial, Size 20x60x5 mm, 8° |
| 10888857391765 | Lordotic Trial, Size 20x60x7 mm, 8° |
| 10888857391758 | Lordotic Trial, Size 20x60x6 mm, 8° |
| 10888857391741 | Lordotic Trial, Size 20x60x5 mm, 8° |
| 10888857390379 | Parallel Trial, Size 20x60x7 mm |
| 10888857390362 | Parallel Trial, Size 20x60x6 mm |
| 10888857390355 | Parallel Trial, Size 20x60x5 mm |
| 10888857189324 | Angled Lateral Inserter Driver |
| 10888857189256 | 22 mm Lateral Box Chisel Size 15 mm |
| 10888857189232 | 22 mm Lateral Box Chisel Size 13 mm |
| 10888857189218 | 22 mm Lateral Box Chisel Size 11 mm |
| 10888857189195 | 22 mm Lateral Box Chisel Size 9 mm |
| 10888857189171 | 22 mm Lateral Box Chisel Size 7 mm |
| 10888857189157 | 22 mm Lateral Box Chisel Size 5 mm |
| 10888857189140 | 22 mm Lateral Box Chisel Size 4 mm |
| 10888857189089 | 18 mm Lateral Box Chisel Size 15 mm |
| 10888857189065 | 18 mm Lateral Box Chisel Size 13 mm |
| 10888857189041 | 18 mm Lateral Box Chisel Size 11 mm |
| 10888857189027 | 18 mm Lateral Box Chisel Size 9 mm |
| 10888857189003 | 18 mm Lateral Box Chisel Size 7 mm |
| 10888857188983 | 18 mm Lateral Box Chisel Size 5 mm |
| 10888857188976 | 18 mm Lateral Box Chisel Size 4 mm |
| 10888857188969 | Lordotic Angled Trial Size 22x60x16 mm |
| 10888857188921 | Lordotic Angled Trial Size 22x60x14 mm |
| 10888857188884 | Lordotic Angled Trial Size 22x60x12 mm |
| 10888857188846 | Lordotic Angled Trial Size 22x60x10 mm |
| 10888857188808 | Lordotic Angled Trial Size 22x60x8 mm |
| 10888857188785 | Parallel Angled Trial Size 22x60x16 mm |
| 10888857188761 | Parallel Angled Trial Size 22x60x14 mm |
| 10888857188723 | Parallel Angled Trial Size 22x60x12 mm |
| 10888857188686 | Parallel Angled Trial Size 22x60x10 mm |
| 10888857188648 | Parallel Angled Trial Size 22x60x8 mm |
| 10888857188600 | Lordotic Angled Trial Size 18x60x16 mm |
| 10888857188563 | Lordotic Angled Trial Size 18x60x14 mm |
| 10888857188525 | Lordotic Angled Trial Size 18x60x12 mm |
| 10888857188488 | Lordotic Angled Trial Size 18x60x10 mm |
| 10888857188440 | Lordotic Angled Trial Size 18x60x8 mm |
| 10888857188402 | Parallel Angled Trial Size 18x60x16 mm |
| 10888857188365 | Parallel Angled Trial Size 18x60x14 mm |
| 10888857188327 | Parallel Angled Trial Size 18x60x12 mm |
| 10888857188280 | Parallel Angled Trial Size 18x60x10 mm |
| 10888857188242 | Parallel Angled Trial Size 18x60x8 mm |
| 10888857188204 | Slap Hammer Adapter |
| 10888857188181 | Trial Handle |
| 10888857188174 | Slap Hammer |