VUZE System
by Vuze Medical Ltd 2 variants
510(k) K210830
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210830 | Date3 Jan 2022 | StatusActive |
Official records
- FDA 510(k) database K210830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Vuze Medical , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The VUZE System is a software-based surgical guidance system designed to assist during spine surgeries performed manually on short spinal segments. It operates as a software-only complement to traditional hardware-based navigation, providing guidance using standard 2D X-ray imaging and a PC. The system is designed to work with unmodified surgical tools without requiring tool add-ons, cameras, markers, or external references.
The system is primarily aimed for use in outpatient and ambulatory surgical settings. It received initial U.S. FDA 510(k) clearance in 2022 under submission number K210830.
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