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 a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2018-02-07 under approval 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. It is manufactured by Orthofix Srl. The 510(k) number is K172698.
When was G-Beam Fusion Beaming System approved by the FDA?
G-Beam Fusion Beaming System received FDA 510(k) clearance on 2018-02-07, under approval number K172698.
What company makes G-Beam Fusion Beaming System?
G-Beam Fusion Beaming System is manufactured by Orthofix Srl.
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.
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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.