| 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 |
| 10888857578869 - Navigation Instruments | 2025-02-18 Polyaxial Screw Inserter |
| 10888857583252 - SERENGETI® MI Retractor System | 2025-02-17 Gelpi Retractor 100 mm, R |
| 10888857583269 - SERENGETI® MI Retractor System | 2025-02-17 Gelpi Retractor 100 mm, L |
| 10888857583276 - SERENGETI® MI Retractor System | 2025-02-17 Gelpi Retractor 70 mm, R |
| 10888857583283 - SERENGETI® MI Retractor System | 2025-02-17 Gelpi Retractor 70 mm, L |
| 10888857583306 - Navigation Instruments | 2025-02-17 Polyaxial Screw Inserter |
| 10888857262331 - MESA® Small Stature Spinal System | 2025-02-13 Transverse Connector, Semi- Adjustable Size 20 mm MESA Rail™-Rail |
| 10888857262362 - MESA® Small Stature Spinal System | 2025-02-13 Transverse Connector, Semi- Adjustable Size 29 mm MESA Rail™-Rail |