Cleared Traditional

Galileo Vertebral Body Replacement Device

K192145 · Bright Spine · Orthopedic

Apr 2020

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K192145 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 April 21, 2020, 257 days after receiving the submission on August 8, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K192145 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 08, 2019
Decision Date	April 21, 2020
Days to Decision	257 days
Submission Type	Traditional
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.