Galaxy UNYCO System
K-Number: K170146 · 2017-10-12
ApplicantOrthofix Srl
Decision Date2017-10-12
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Galaxy UNYCO System is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2017-10-12 under approval number K170146. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Galaxy UNYCO System?
Galaxy UNYCO System is a medical device that received FDA 510(k) clearance on 2017-10-12. It is manufactured by Orthofix Srl. The 510(k) number is K170146.
When was Galaxy UNYCO System approved by the FDA?
Galaxy UNYCO System received FDA 510(k) clearance on 2017-10-12, under approval number K170146.
What company makes Galaxy UNYCO System?
Galaxy UNYCO System is manufactured by Orthofix Srl.
What is the FDA product code for Galaxy UNYCO System?
The FDA product code for Galaxy UNYCO System is KTT.
Other Devices by Orthofix Srl
K153233Galaxy UNYCO System
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K173051Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
K170650Orthofix TrueLok Hexapod System (TL-HEX) V2.0
K161466ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
K180624Guided Growth Plate System Plus
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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.