VUZE System 2.0
- Primary DI
- 07290019776000
- Brand
- VUZE System 2.0
- Company
- VUZE MEDICAL LTD
- Model
- VM-PK-001
- Catalog number
- VM-PK-001
- Device description
- The VUZE System (the “System”) enables users to load pre-operative 3D images and planning data and register and overlay this data in real time with intra-operative 2D radiographic images of the same anatomy. The System supports device guidance during minimally invasive spinal surgery, including the stabilization of the spine by means of fixation, fixation coupled with fusion, vertebroplasty or kyphoplasty. Applicable vertebrae are within the range of S1 through T7. The user of the VUZE System is a surgeon with the required qualifications for performing applicable spine surgeries. The System offers pre-operative surgical planning, including implant screw sizing and trajectory determination, as well as intra-operative assistance along the insertion of typical surgical tools (including tools used for placing implants) relative to rigid spinal structures.
- Published
- 2024-10-30
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K232976 | 000 | VUZE System | Vuze Medical , Ltd. | 2024-05-09 | LLZ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290019776017 | Package | GS1 | 1 | In Commercial Distribution |
| 07290019776000 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290019776017 | 07290019776017 | 7290019776017 |
| 07290019776000 | 07290019776000 | 7290019776000 |
GMDN Terms
| Term | Definition |
|---|
| Diagnostic x-ray digital imaging system workstation | A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system. |
Regulatory Flags
- DUNS number
- 532208847
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices Sharing Product Codes