| Primary Device ID | 10888857581708 |
| NIH Device Record Key | 453dbf66-156b-465a-9367-7a6725146415 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ES2® Spinal System |
| Version Model Number | PRO-1406 |
| Catalog Number | PRO-1406 |
| Company DUNS | 146060863 |
| Company Name | K2M, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com | |
| Phone | +1(571)919-2000 |
| christopher.tomea@stryker.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10888857581708 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
[10888857581708]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
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| 10888857469655 - TERRA NOVA® MI Access System | 2025-09-19 Retractor Frame |
| 10888857017214 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 9 mm |
| 10888857017221 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 11 mm |
| 10888857017245 - ALEUTIAN® Interbody Systems | 2025-09-17 Disc Spreader Size 13 mm |
| 10888857017290 - ALEUTIAN® Interbody Systems | 2025-09-17 Anterior Pituitary Rongeur (Up) Size 13" 4 mm 45° |
| 10888857115255 - ALEUTIAN® Interbody Systems | 2025-09-17 Rasp Size 13x24x30 mm |
| 10888857115262 - ALEUTIAN® Interbody Systems | 2025-09-17 Rasp Size 15x24x30 mm |