DeviceClearance

Product code PLR— Orthopedic

Galileo Vertebral Body Replacement Device

Classification name
Spinal Vertebral Body Replacement Device - Cervical
Device class
Class 2
Regulation
21 CFR 888.3060
Advisory panel
Orthopedic
Total cleared
19
First cleared
Most recent

FDA classification definition

“Vertebral body replacement in the cervical spine.”

— U.S. Food and Drug Administration, device classification record for product code PLR under 21 CFR 888.3060, via openFDA

Market context for product code PLR

FDA has cleared 19 devices under product code PLR between 2015 and 2026, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLR

Recent clearances under product code PLR

Data sourced from openFDA. This site is unofficial and independent of the FDA.