Cleared Special

Galileo Vertebral Body Replacement Device

K221542 · Bright Spine · Orthopedic

Jan 2023

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K221542 is an FDA 510(k) clearance for the Galileo Vertebral Body Replacement Device, a Spinal Vertebral Body Replacement Device - Cervical (Class II — Special Controls, product code PLR), submitted by Bright Spine (Boca Raton, US). The FDA issued a Cleared decision on January 13, 2023, 231 days after receiving the submission on May 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K221542 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2022
Decision Date	January 13, 2023
Days to Decision	231 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PLR — Spinal Vertebral Body Replacement Device - Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3060
Definition	Vertebral Body Replacement In The Cervical Spine.