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FDA 510(k)

Galaxy UNYCO System

K-Number: K153233 · 2016-01-06

ApplicantOrthofix Srl
Decision Date2016-01-06
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Galaxy UNYCO 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 2016-01-06 under 510(k) number K153233. 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 2016-01-06. The listed applicant is Orthofix Srl. The 510(k) number is K153233.

When did Galaxy UNYCO System receive FDA 510(k) clearance?

Galaxy UNYCO System received FDA 510(k) clearance on 2016-01-06, under 510(k) number K153233.

Who is the listed applicant for Galaxy UNYCO 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 Galaxy UNYCO System?

The FDA product code for Galaxy UNYCO System is KTT.

Other records listing Orthofix Srl as applicant

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Related Devices (Code: KTT)

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.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

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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