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FDA 510(k)

Galileo Vertebral Body Replacement Device

K-Number: K221542 · 2023-01-13

ApplicantBright Spine
Decision Date2023-01-13
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Galileo Vertebral Body Replacement Device is a medical device manufactured by Bright Spine. It received FDA 510(k) clearance on 2023-01-13 under approval number K221542. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Galileo Vertebral Body Replacement Device?

Galileo Vertebral Body Replacement Device is a medical device that received FDA 510(k) clearance on 2023-01-13. It is manufactured by Bright Spine. The 510(k) number is K221542.

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

Galileo Vertebral Body Replacement Device received FDA 510(k) clearance on 2023-01-13, under approval number K221542.

What company makes Galileo Vertebral Body Replacement Device?

Galileo Vertebral Body Replacement Device is manufactured by Bright Spine.

What is the FDA product code for Galileo Vertebral Body Replacement Device?

The FDA product code for Galileo Vertebral Body Replacement Device is PLR.

Related Clinical Trials

NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT07598760 Clinical Feasibility of Cardiac Neuromodulation Therapy for Heart Failure With Preserved Ejection Fraction NOT_YET_RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT04100720 Early Feasibility Study of the Cardiovalve System for Tricuspid Regurgitation WITHDRAWN NCT07442903 TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure RECRUITING

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025)

Other Devices by Bright Spine

K192145Galileo Vertebral Body Replacement Device

Related Devices (Code: PLR)

K152568C-VBRCardinal Spine, LLC K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc. K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated K173893TrabisColigne AG K180673Normandy VBR SystemZavation Medical Products, LLC K190284Bengal Stackable Cage SystemMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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