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)

G-Beam Fusion Beaming System

K-Number: K172698 · 2018-02-07

ApplicantOrthofix Srl
Decision Date2018-02-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G-Beam Fusion Beaming System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2018-02-07 under 510(k) number K172698. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-Beam Fusion Beaming System?

G-Beam Fusion Beaming System is a medical device that received FDA 510(k) clearance on 2018-02-07. The listed applicant is Orthofix Srl. The 510(k) number is K172698.

When did G-Beam Fusion Beaming System receive FDA 510(k) clearance?

G-Beam Fusion Beaming System received FDA 510(k) clearance on 2018-02-07, under 510(k) number K172698.

Who is the listed applicant for G-Beam Fusion Beaming System?

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

What is the FDA product code for G-Beam Fusion Beaming System?

The FDA product code for G-Beam Fusion Beaming System is HWC. This falls under the Cardiovascular category.

Other records listing Orthofix Srl 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.

K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMK253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAK250112FitboneTM TrochantericK242270OrthoNext Platform SystemK242861TrueLok ElevateK233867Fitbone Trochanteric

View all 24 devices →

Related Devices (Code: HWC)

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.

K262344Large Compression ScrewsTriMed, Inc.K253858GFS - Sterile Screws and Top HatT.A.G. Medical Products Corporation, Ltd.K262075Lapidus Screw KitRelja Innovations, LLCK260809Arthrex Sterile VAL and VAL KreuLock™ Compression Screw SystemArthrex, Inc.K253108VEOFIX Snap Off ScrewSteps OrthoK261154CoLink® & CoLag® Non-Sterile ScrewsIn2Bones USA, LLC

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.

↑