Galileo Vertebral Body Replacement Device— 510(k) K221542

Name: FDA 510(k) clearance K221542
Creator: U.S. Food and Drug Administration
Published: 2023-01-13

Substantially Equivalent

Bright Spine

FDA 510(k) clearance K221542 for Galileo Vertebral Body Replacement Device, Substantially Equivalent on 2023-01-13. Applicant: Bright Spine. Device class: 2.

Clearance details

Applicant: Bright Spine
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2022-05-27
Decision date: 2023-01-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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