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FDA 510(k)

NEO Pedicle Screw System™

K-Number: K171582 · 2017-09-12

ApplicantNeo Medical SA
Decision Date2017-09-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NEO Pedicle Screw System™ is a medical device manufactured by Neo Medical SA. It received FDA 510(k) clearance on 2017-09-12 under approval number K171582. 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 NEO Pedicle Screw System™?

NEO Pedicle Screw System™ is a medical device that received FDA 510(k) clearance on 2017-09-12. It is manufactured by Neo Medical SA. The 510(k) number is K171582.

When was NEO Pedicle Screw System™ approved by the FDA?

NEO Pedicle Screw System™ received FDA 510(k) clearance on 2017-09-12, under approval number K171582.

What company makes NEO Pedicle Screw System™?

NEO Pedicle Screw System™ is manufactured by Neo Medical SA.

What is the FDA product code for NEO Pedicle Screw System™?

The FDA product code for NEO 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 Neo Medical SA

K191796Neo Cage System K181048Neo Cage System TM K212489BonOs Inject Bone Cement; NEO Pedicle Screw System K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™ K243693NEO Pedicle Screw System™

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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