FDA UDI
In Commercial Distribution
🇺🇸 United States
VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm
DI: 07640172552919
·
Model: 42-542-1
·
icotec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm
- Primary DI
- 07640172552919
- Version / Model
- 42-542-1
- Catalog Number
- 42-542-1
- Company Name
- icotec AG
- Labeler DUNS
- 480789465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-22
- Public Version
- 3
- Public Version Date
- 2026-03-19
- Public Version Status
- Update
- Public Device Record Key
- df6b7996-5e18-478e-89a1-cf0d001c3a40
Device Description
VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PML | Bone Cement, Posterior Screw Augmentation | Orthopedic | 888.3027 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66936 | Spinal intraoperative positioning/manipulation pin, reusable | A nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded, however as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640172552919 | GS1 |
Customer Contacts
- Phone
- +417570000
- [email protected]