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FDA 510(k)

Europa Pedicle Screw System

K-Number: K192268 · 2019-10-22

ApplicantMiRus, LLC
Decision Date2019-10-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Europa Pedicle Screw System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2019-10-22 under approval number K192268. 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 Europa Pedicle Screw System?

Europa Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by MiRus, LLC. The 510(k) number is K192268.

When was Europa Pedicle Screw System approved by the FDA?

Europa Pedicle Screw System received FDA 510(k) clearance on 2019-10-22, under approval number K192268.

What company makes Europa Pedicle Screw System?

Europa Pedicle Screw System is manufactured by MiRus, LLC.

What is the FDA product code for Europa Pedicle Screw System?

The FDA product code for Europa Pedicle Screw System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED NCT06720948 The ION Facet Screw System Ambispective Evaluation ENROLLING_BY_INVITATION NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement RECRUITING

Related PubMed Literature

PMID: 38493931 Establishing finite element model credibility of a pedicle screw system under compression-bending: An end-to-end example of the ASME V&V 40 standard. Methods (San Diego, Calif.) (2024) PMID: 37209414 Adverse events associated with Aveir Journal of cardiovascular electrophysiology (2023) PMID: 30035086 Translational research of one dynamic hip screw system-from the SCI to the FDA. Journal of orthopaedic translation (2016)

Other Devices by MiRus, LLC

K182989AURORA™ Screw System K191757EUROPA Pedicle Screw System K182524GALILEO Spine Alignment Monitoring System K190618RIGEL PEEK Anterior Cervical Interbody Fusion System K190666CYGNUS™ Anterior Cervical Plate System K190415ATLAS Plating 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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