FDA UDI
In Commercial Distribution
🇺🇸 United States
KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm
DI: 07640164847412
·
Model: 12-91-1922-9
·
icotec AG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm
- Primary DI
- 07640164847412
- Version / Model
- 12-91-1922-9
- Catalog Number
- 12-91-1922-9
- Company Name
- icotec AG
- Labeler DUNS
- 480789465
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-19
- Public Version
- 1
- Public Version Date
- 2020-06-29
- Public Version Status
- New
- Public Device Record Key
- a46ffbc3-f99d-4aee-bad7-c2af911e472c
Device Description
KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mm
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQP | Spinal Vertebral Body Replacement Device | Orthopedic | 888.3060 | 2 |
| PLR | Spinal Vertebral Body Replacement Device - Cervical | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34170 | Vertebral body prosthesis | An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640164847412 | GS1 |
Customer Contacts
- Phone
- +41717570000
- [email protected]