FDA 510(k)

INERTIA® CONNEXX Modular Pedicle Screw System

K-Number: K231799 · 2023-07-20

Decision Date2023-07-20

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INERTIA® CONNEXX Modular Pedicle Screw System is a medical device manufactured by Nexxt Spine, LLC. It received FDA 510(k) clearance on 2023-07-20 under approval number K231799. 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 INERTIA® CONNEXX Modular Pedicle Screw System?

INERTIA® CONNEXX Modular Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Nexxt Spine, LLC. The 510(k) number is K231799.

When was INERTIA® CONNEXX Modular Pedicle Screw System approved by the FDA?

INERTIA® CONNEXX Modular Pedicle Screw System received FDA 510(k) clearance on 2023-07-20, under approval number K231799.

What company makes INERTIA® CONNEXX Modular Pedicle Screw System?

INERTIA® CONNEXX Modular Pedicle Screw System is manufactured by Nexxt Spine, LLC.

What is the FDA product code for INERTIA® CONNEXX Modular Pedicle Screw System?

The FDA product code for INERTIA® CONNEXX Modular Pedicle Screw System is NKB.

Related Clinical Trials

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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 Nexxt Spine, LLC

K153453Inertia Pedicle Screw and Deformity Correxxion System K171140Matrixx System K182508Saxxony Posterior Cervical Thoracic System K191408Nexxt Matrixx System K190546NEXXT MATRIXX Stand Alone Cervical System K202230NEXXT MATRIXX Stand Alone ALIF 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.