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VUZE System 2.0

FDA UDI

Class II (US FDA UDI)

by Vuze Medical , Ltd.

Identity

Trade Name
VUZE System 2.0 FDA UDI
Generic Name
Diagnostic x-ray digital imaging system workstation FDA UDI
Device Name
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. FDA UDI
Model / Reference
VM-PK-001 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
VM-PK-001 FDA UDI
Primary DI / UDI-DI
07290019776000 FDA UDI
510(k) Number
K232976 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Diagnostic x-ray digital imaging system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray digital imaging system workstation

VUZE System 2.0 by Vuze Medical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray digital imaging system workstation.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vuze Medical , Ltd.

Sources (1)

  • FDA UDI 25c0399a-6df6-4b75-b8f8-e624fad779da 35 fields · synced Jun 6, 2026