| Primary Device ID | 10888857455276 |
| NIH Device Record Key | ddfa40aa-73bb-4319-866b-619559f4bab6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOJAVE Expandable Interbody System |
| Version Model Number | 7012-90111 |
| Catalog Number | 7012-90111 |
| 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(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com | |
| Phone | +1(703)777-3155 |
| mzellers@k2m.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857455276 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
[10888857455276]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-19 |
| Device Publish Date | 2019-11-11 |
| 10888857398627 | Inserter Inner Shaft |
| 10888857394100 | Expandable Interbody Inserter, Size Long |
| 10888857394025 | Expansion Driver, Size Long |
| 10888857391703 | Inner Shaft |
| 10888857391697 | Driver, Size 8 |
| 10888857386518 | Convex Trial, Size 13x28/32x15 mm |
| 10888857386501 | Convex Trial, Size 13x28/32x14 mm |
| 10888857386495 | Convex Trial, Size 13x28/32x13 mm |
| 10888857386488 | Convex Trial, Size 13x28/32x12 mm |
| 10888857386471 | Convex Trial, Size 13x28/32x11 mm |
| 10888857386464 | Convex Trial, Size 13x28/32x10 mm |
| 10888857386457 | Convex Trial, Size 13x28/32x9 mm |
| 10888857386440 | Convex Trial, Size 13x28/32x8 mm |
| 10888857386433 | Convex Trial, Size 13x28/32x7 mm |
| 10888857386426 | Convex Trial, Size 13x24/28x15 mm |
| 10888857386419 | Convex Trial, Size 13x24/28x14 mm |
| 10888857386402 | Convex Trial, Size 13x24/28x13 mm |
| 10888857386396 | Convex Trial, Size 13x24/28x12 mm |
| 10888857386389 | Convex Trial, Size 13x24/28x11 mm |
| 10888857386372 | Convex Trial, Size 13x24/28x10 mm |
| 10888857386365 | Convex Trial, Size 13x24/28x9 mm |
| 10888857386358 | Convex Trial, Size 13x24/28x8 mm |
| 10888857386341 | Convex Trial, Size 13x24/28x7 mm |
| 10888857385788 | Convex Trial, Size 11x28/32x15 mm |
| 10888857385771 | Convex Trial, Size 11x28/32x14 mm |
| 10888857385764 | Convex Trial, Size 11x28/32x13 mm |
| 10888857385757 | Convex Trial, Size 11x28/32x12 mm |
| 10888857385740 | Convex Trial, Size 11x28/32x11 mm |
| 10888857385733 | Convex Trial, Size 11x28/32x10 mm |
| 10888857385726 | Convex Trial, Size 11x28/32x9 mm |
| 10888857385719 | Convex Trial, Size 11x28/32x8 mm |
| 10888857385702 | Convex Trial, Size 11x28/32x7 mm |
| 10888857384026 | Convex Trial, Size 11x24/28x15 mm |
| 10888857384019 | Convex Trial, Size 11x24/28x14 mm |
| 10888857384002 | Convex Trial, Size 11x24/28x13 mm |
| 10888857383999 | Convex Trial, Size 11x24/28x12 mm |
| 10888857383982 | Convex Trial, Size 11x24/28x11 mm |
| 10888857383975 | Convex Trial, Size 11x24/28x10 mm |
| 10888857383968 | Convex Trial, Size 11x24/28x9 mm |
| 10888857383951 | Convex Trial, Size 11x24/28x8 mm |
| 10888857383944 | Convex Trial, Size 11x24/28x7 mm |
| 10888857383265 | Expandable Interbody with Set Screw, Size 13x32x9-12 mm |
| 10888857383258 | Expandable Interbody with Set Screw, Size 13x32x8-11 mm |
| 10888857383241 | Expandable Interbody with Set Screw, Size 13x32x7-10 mm |
| 10888857383234 | Expandable Interbody with Set Screw, Size 11x32x9-12 mm |
| 10888857383227 | Expandable Interbody with Set Screw, Size 11x32x8-11 mm |
| 10888857383210 | Expandable Interbody with Set Screw, Size 11x32x7-10 mm |
| 10888857383203 | Expandable Interbody with Set Screw, Size 13x28x9-12 mm |
| 10888857383197 | Expandable Interbody with Set Screw, Size 13x28x8-11 mm |
| 10888857383180 | Expandable Interbody with Set Screw, Size 13x28x7-10 mm |