| Primary Device ID | 00190837143275 |
| NIH Device Record Key | 40e24621-7c5d-4187-8a2f-4730a3593dc7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Arx |
| Version Model Number | 14550-095 |
| Company DUNS | 183641617 |
| Company Name | Life Spine, 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190837143275 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
[00190837143275]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
| 00190837075514 | Polyaxial Non-Cannulated Screw, 10.5x30mm |
| 00190837075507 | Polyaxial Non-Cannulated Screw, 10.5x 25mm |
| 00190837075453 | Polyaxial Non-Cannulated Screw, 10.5x55mm |
| 00190837075446 | Polyaxial Non-Cannulated Screw, 10.5x50mm |
| 00190837075439 | Polyaxial Non-Cannulated Screw, 10.5x45mm |
| 00190837075422 | Polyaxial Non-Cannulated Screw, 10.5x40mm |
| 00190837075415 | Polyaxial Non-Cannulated Screw, 10.5x35mm |
| 00190837075200 | Polyaxial Cannulated Screw 10.5x120mm |
| 00190837075194 | Polyaxial Cannulated Screw 10.5x110mm |
| 00190837075057 | Polyaxial Cannulated Screw (Closed) 9.5x120mm |
| 00190837075040 | Polyaxial Cannulated Screw (Closed) 9.5x110mm |
| 00190837075033 | Polyaxial Cannulated Screw (Closed) 9.5x100mm |
| 00190837075026 | Polyaxial Cannulated Screw (Closed) 9.5x90mm |
| 00190837075019 | Polyaxial Cannulated Screw (Closed) 9.5x80mm |
| 00190837075002 | Polyaxial Cannulated Screw (Closed) 9.5x70mm |
| 00190837074999 | Polyaxial Cannulated Screw 9.5x60mm |
| 00190837074968 | Polyaxial Cannulated Screw (Closed) 8.5x100mm |
| 00190837074951 | Polyaxial Cannulated Screw (Closed) 8.5x80mm |
| 00190837074920 | Polyaxial Cannulated Screw 8.5x60mm |
| 00190837074845 | Polyaxial Cannulated Screw 10.5x100mm |
| 00190837074838 | Polyaxial Cannulated Screw 10.5x90mm |
| 00190837074821 | Polyaxial Cannulated Screw 10.5x80mm |
| 00190837074814 | Polyaxial Cannulated Screw 10.5x70mm |
| 00190837074807 | Polyaxial Cannulated Screw 10.5x60mm |
| 00190837074265 | Closed Tulip Lock Screw |
| 00190837074258 | Polyaxial Non-Cannulated Screw (Closed) 9.5x90mm |
| 00190837074241 | Polyaxial Non-Cannulated Screw (Closed) 9.5x80mm |
| 00190837074234 | Polyaxial Non-Cannulated Screw (Closed) 9.5x70mm |
| 00190837074227 | Polyaxial Non-Cannulated Screw (Closed) 9.5x60mm |
| 00190837074210 | Polyaxial Non-Cannulated Screw (Closed) 9.5x120mm |
| 00190837074203 | Polyaxial Non-Cannulated Screw (Closed) 9.5x110mm |
| 00190837074197 | Polyaxial Non-Cannulated Screw (Closed) 9.5x100mm |
| 00190837074173 | Polyaxial Non-Cannulated Screw (Closed) 8.5x80mm |
| 00190837074166 | Polyaxial Non-Cannulated Screw (Closed) 8.5x70mm |
| 00190837074135 | Polyaxial Non-Cannulated Screw (Closed) 8.5x110mm |
| 00190837074128 | Polyaxial Non-Cannulated Screw (Closed) 8.5x100mm |
| 00190837074111 | Polyaxial Non-Cannulated Screw (Closed) 7.5x90mm |
| 00190837073893 | Polyaxial Non-Cannulated Screw, 10.5x90mm |
| 00190837073886 | Polyaxial Non-Cannulated Screw, 10.5x80mm |
| 00190837073879 | Polyaxial Non-Cannulated Screw, 10.5x70mm |
| 00190837073862 | Polyaxial Non-Cannulated Screw, 10.5x60mm |
| 00190837073855 | Polyaxial Non-Cannulated Screw 10.5x120mm |
| 00190837073848 | Polyaxial Non-Cannulated Screw 10.5x110mm |
| 00190837073831 | Polyaxial Non-Cannulated Screw, 10.5x100mm |
| 00190837036324 | Table Mount. Rod Cutter |
| 00190837036317 | ARX Thoracolumbar Screw Assembly; 8.5mm x 55mm |
| 00190837036300 | ARX Thoracolumbar Screw Assembly; 8.5mm x 50mm |
| 00190837036294 | ARX Thoracolumbar Screw Assembly; 8.5mm x 45mm |
| 00190837036287 | ARX Thoracolumbar Screw Assembly; 8.5mm x 40mm |
| 00190837036270 | ARX Thoracolumbar Screw Assembly; 8.5mm x 35mm |