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FDA 510(k)

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System

K-Number: K153428 · 2016-01-29

ApplicantOrthofix, Inc.
Decision Date2016-01-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K153428. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System?

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Orthofix, Inc.. The 510(k) number is K153428.

When was Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System approved by the FDA?

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System received FDA 510(k) clearance on 2016-01-29, under approval number K153428.

What company makes Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System?

Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System is manufactured by Orthofix, Inc..

What is the FDA product code for Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System?

The FDA product code for Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Orthofix, Inc.

K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System K162638CETRA Anterior Cervical Plate System K161129PILLAR SA PTC K161280Cervical Stand Alone System K152475FORZA PTC Spacer System K172437CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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.

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