| Primary Device ID | 07640172553855 |
| NIH Device Record Key | 13269d72-5703-4a79-b787-ee58203d326d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | icotec Systems, Fixation device |
| Version Model Number | 42-893 |
| Catalog Number | 42-893 |
| Company DUNS | 480789465 |
| Company Name | icotec AG |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch | |
| Phone | +41717570000 |
| info@icotec.ch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640172553855 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
[07640172553855]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-21 |
| Device Publish Date | 2025-08-13 |
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| 07640172553848 - icotec Systems, Handle, 1/4" Coupling | 2025-08-21 icotec Systems, Handle, 1/4" Coupling |
| 07640172553855 - icotec Systems, Fixation device | 2025-08-21icotec Systems, Fixation device |
| 07640172553855 - icotec Systems, Fixation device | 2025-08-21 icotec Systems, Fixation device |
| 07640172553862 - icotec Systems, Deburring tool | 2025-08-21 icotec Systems, Deburring tool |
| 07640172553879 - icotec Systems, Handle for deburrer, M6 | 2025-08-21 icotec Systems, Handle for deburrer, M6 |
| 07640172553831 - icotec Systems, Navigation Adapter | 2025-08-20 icotec Systems, Navigation Adapter |
| 07640172551967 - VADER Pedicle System, Handle, 1/4" Coupling | 2025-08-07 VADER Pedicle System, Handle, 1/4" Coupling |
| 07640172551981 - VADER Pedicle System, Deburring tool | 2025-08-07 VADER Pedicle System, Deburring tool |