| Primary Device ID | 07640164849614 |
| NIH Device Record Key | 580074b3-09f6-49ce-b46d-d3c6e00254e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icotec Pedicle System 6.0, Screw, Ti, Polyax., Fen., Ø 8.5 x 55 mm |
| Version Model Number | 16-6022-98555 |
| 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 |
| 07640172552278 - VADER Pedicle System K-wire Dispenser, long For K-wire 1.6 x 472 mm, 1.1 x 472 m | 2025-06-03 VADER Pedicle System K-wire Dispenser, long For K-wire 1.6 x 472 mm, 1.1 x 472 mm |
| 07640172552858 - VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm | 2025-03-13 VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm |
| 07640172552865 - VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm | 2025-03-13 VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm |
| 07640172552872 - icotec Systems, Torque-Limiting Adapter, 3.5 Nm | 2025-03-13 icotec Systems, Torque-Limiting Adapter, 3.5 Nm |
| 07640172552889 - VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm | 2025-03-13 VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm |
| 07640172553572 - VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm | 2025-03-13 VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm |
| 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 |