FDA 510(k)

Swedge Pedicle Screw Fixation System

K-Number: K230482 · 2023-03-23

Decision Date2023-03-23

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Swedge Pedicle Screw Fixation System is a medical device manufactured by Spinal Resources, Inc.. It received FDA 510(k) clearance on 2023-03-23 under approval number K230482. 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 Swedge Pedicle Screw Fixation System?

Swedge Pedicle Screw Fixation System is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by Spinal Resources, Inc.. The 510(k) number is K230482.

When was Swedge Pedicle Screw Fixation System approved by the FDA?

Swedge Pedicle Screw Fixation System received FDA 510(k) clearance on 2023-03-23, under approval number K230482.

What company makes Swedge Pedicle Screw Fixation System?

Swedge Pedicle Screw Fixation System is manufactured by Spinal Resources, Inc..

What is the FDA product code for Swedge Pedicle Screw Fixation System?

The FDA product code for Swedge Pedicle Screw Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41487949 Verification, validation, and uncertainty quantification of finite element analysis results for pedicle screw assemblies under ASTM F1717 flexion and extension testing. Frontiers in bioengineering and biotechnology (2025)

Other Devices by Spinal Resources, Inc.

K152662S-Wire K170045Swedge Pedicle Screw Fixation System K252461Swedge Pedicle Screw Fixation System Bezier Rod

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.