| Primary Device ID | 10888857580374 |
| NIH Device Record Key | deea3bbc-1120-4e76-869a-40a03573d613 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xia® 3 System - Serrato® |
| Version Model Number | PRO-1370 |
| Catalog Number | PRO-1370 |
| 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 |
| 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 | 10888857580374 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
[10888857580374]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-29 |
| Device Publish Date | 2024-08-21 |
| 10888857262348 - MESA® Small Stature Spinal System | 2025-01-30 Transverse Connector, Semi- Adjustable Size 23 mm MESA Rail™-Rail |
| 10888857262355 - MESA® Small Stature Spinal System | 2025-01-30 Transverse Connector, Semi- Adjustable Size 26 mm MESA Rail™-Rail |
| 10888857262386 - MESA® Small Stature Spinal System | 2025-01-30 Transverse Connector, Semi- Adjustable Size 35 mm MESA Rail™-Rail |
| 10888857262423 - MESA® Small Stature Spinal System | 2025-01-30 Transverse Connector, Semi- Adjustable Size 26 mm MESA Rail™-Rod |
| 10888857551824 - Oasys® | 2025-01-23 Inserter |
| 10888857007529 - DENALI® Spinal System | 2025-01-21 Lateral Offset Connector Size 50 mm |
| 10888857008502 - DENALI® Spinal System | 2025-01-21 Buttress Ring Size Ø5.5 mm |
| 10888857525801 - CASCADIA™ Interbody System | 2024-11-12 AN Inserter Inner Shaft |