Orthopedics
UNiD Spine Analyzer
Medicrea International S.A.S. (Medtronic)
FDAHC
FDA-cleared AI medical device
Web-based software that assists healthcare professionals in viewing and measuring images and planning orthopaedic surgery, letting surgeons and service providers perform generic and spine-related measurements, plan procedures and measure anatomical components for the placement of surgical implants; clinical judgement and experience are required to use it.
FDA Submission Metadata
- Submission number
- K180091
- Decision date
- February 2018
- FDA panel
- Radiology
- Product code
- LLZ
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals