Galileo Vertebral Body Replacement Device

FDA 510(k) K221542 · Bright Spine

Substantially Equivalent

510(k) numberK221542

Submission

Device name
Galileo Vertebral Body Replacement Device
Applicant
Bright Spine
Boca Raton, FL, US
Received
May 27, 2022
Decision date
January 13, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PLR – Spinal Vertebral Body Replacement Device - Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

Vertebral body replacement in the cervical spine.

Other 510(k)s with product code PLR

510(k)DeviceApplicantDecision
K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantPLR · Traditional Atlas Spine, Inc.07/15/2026SE
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemPLR · Traditional Atlas Spine, Inc.11/10/2025SE
K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemPLR · Traditional MiRus, LLC10/13/2023SE
K212126MediExpand Cervical Expandable VBR SystemPLR · Traditional Cmf Medicon Surgical, Inc.04/04/2022SE
K211320CAPRI Corpectomy Cage SystemPLR · Traditional K2m, Inc.02/24/2022SE
K192145Galileo Vertebral Body Replacement DevicePLR · Traditional Bright Spine04/21/2020SE
K193412NEXXT MATRIXX SystemPLR · Traditional Nexxt Spine, LLC02/24/2020SE
K190284Bengal Stackable Cage SystemPLR · Traditional Medos International SARL12/20/2019SE
K190426ALTA Anterior Cervical Corpectomy SystemPLR · Traditional Astura Medical, LLC10/24/2019SE
K191778Omnia Medical VBRPLR · Special Omnia Medical, LLC08/28/2019SE

More from Omnia Medical, LLC

510(k)DeviceDecision
K192145Galileo Vertebral Body Replacement DevicePLR · Traditional 04/21/2020SE
K102449Bright Spine Galileo Spinal Spacer SystemODP · Traditional 02/11/2011SE

Questions and answers

When was Galileo Vertebral Body Replacement Device cleared by the FDA?

Galileo Vertebral Body Replacement Device (K221542) received a 510(k) decision of Substantially Equivalent on January 13, 2023, 231 days after the submission was received.

What is the product code of K221542?

The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.