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FDA 510(k)

DeGen Medical E3 MIS Pedicle Screw System

K-Number: K173814 · 2018-01-29

ApplicantDegen Medical
Decision Date2018-01-29
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DeGen Medical E3 MIS Pedicle Screw System is a medical device manufactured by Degen Medical. It received FDA 510(k) clearance on 2018-01-29 under approval number K173814. 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 DeGen Medical E3 MIS Pedicle Screw System?

DeGen Medical E3 MIS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-01-29. It is manufactured by Degen Medical. The 510(k) number is K173814.

When was DeGen Medical E3 MIS Pedicle Screw System approved by the FDA?

DeGen Medical E3 MIS Pedicle Screw System received FDA 510(k) clearance on 2018-01-29, under approval number K173814.

What company makes DeGen Medical E3 MIS Pedicle Screw System?

DeGen Medical E3 MIS Pedicle Screw System is manufactured by Degen Medical.

What is the FDA product code for DeGen Medical E3 MIS Pedicle Screw System?

The FDA product code for DeGen Medical E3 MIS Pedicle Screw System is NKB.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Degen Medical

K160926F1 MPS Modular Pedicle Screw System K201287Impulse Interbody Fusion System K210090Impulse AM Interbody Fusion System K203816DeGen Navigated Instrumentation K213918DeGen Navigated Instrumentation K213901Cyclops™ Anterior Cervical Plate 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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