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FDA 510(k)

Pantheon Pedicle Screw and Iliac Bolt Fixation System

K-Number: K241494 · 2024-07-26

ApplicantPantheon Spinal
Decision Date2024-07-26
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon Pedicle Screw and Iliac Bolt Fixation System is a medical device manufactured by Pantheon Spinal. It received FDA 510(k) clearance on 2024-07-26 under approval number K241494. 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 Pantheon Pedicle Screw and Iliac Bolt Fixation System?

Pantheon Pedicle Screw and Iliac Bolt Fixation System is a medical device that received FDA 510(k) clearance on 2024-07-26. It is manufactured by Pantheon Spinal. The 510(k) number is K241494.

When was Pantheon Pedicle Screw and Iliac Bolt Fixation System approved by the FDA?

Pantheon Pedicle Screw and Iliac Bolt Fixation System received FDA 510(k) clearance on 2024-07-26, under approval number K241494.

What company makes Pantheon Pedicle Screw and Iliac Bolt Fixation System?

Pantheon Pedicle Screw and Iliac Bolt Fixation System is manufactured by Pantheon Spinal.

What is the FDA product code for Pantheon Pedicle Screw and Iliac Bolt Fixation System?

The FDA product code for Pantheon Pedicle Screw and Iliac Bolt Fixation System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

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 Pantheon Spinal

K181548Pantheon Spinal Pontus Interbody Fusion Device K203003Pantheon IBFD

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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