Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Galileo Vertebral Body Replacement Device

K-Number: K192145 · 2020-04-21

ApplicantBright Spine
Decision Date2020-04-21
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Galileo Vertebral Body Replacement Device is the device name listed in this FDA 510(k) record. The listed applicant is Bright Spine. It received FDA 510(k) clearance on 2020-04-21 under 510(k) number K192145. 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 2020-04-21. The listed applicant is Bright Spine. The 510(k) number is K192145.

When did Galileo Vertebral Body Replacement Device receive FDA 510(k) clearance?

Galileo Vertebral Body Replacement Device received FDA 510(k) clearance on 2020-04-21, under 510(k) number K192145.

Who is the listed applicant for Galileo Vertebral Body Replacement Device?

The FDA 510(k) record lists Bright Spine as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Bright Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221542Galileo Vertebral Body Replacement Device

Related Devices (Code: PLR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, Inc.

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.

↑