| Primary Device ID | 07640164849584 |
| NIH Device Record Key | dd82a8f2-91c2-49ff-863c-2e7f7e83564a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 40 mm |
| Version Model Number | 16-6022-98540 |
| Company DUNS | 480789465 |
| Company Name | icotec AG |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 07640172552896 - VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 | 2024-12-02 VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 |
| 07640172552902 - VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm | 2024-12-02 VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm |
| 07640172552919 - VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm | 2024-12-02 VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm |
| 07640172552827 - VADER Pedicle System Counter Torque Wrench | 2024-10-22 VADER Pedicle System Counter Torque Wrench |
| 07640172552070 - VADER Pedicle System, Rod inserter, for cut rods | 2024-09-11 VADER Pedicle System, Rod inserter, for cut rods |
| 07640172551530 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm | 2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm |
| 07640172551547 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm | 2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm |
| 07640172551554 - VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm | 2024-08-08 VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm |