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FDA 510(k)

Swedge™ Pedicle Screw Fixation System Bezier Rod

K-Number: K252461 · 2026-01-13

ApplicantSpinal Resources, Inc.
Decision Date2026-01-13
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Swedge™ Pedicle Screw Fixation System Bezier Rod is a medical device manufactured by Spinal Resources, Inc.. It received FDA 510(k) clearance on 2026-01-13 under approval number K252461. 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 Bezier Rod?

Swedge™ Pedicle Screw Fixation System Bezier Rod is a medical device that received FDA 510(k) clearance on 2026-01-13. It is manufactured by Spinal Resources, Inc.. The 510(k) number is K252461.

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

Swedge™ Pedicle Screw Fixation System Bezier Rod received FDA 510(k) clearance on 2026-01-13, under approval number K252461.

What company makes Swedge™ Pedicle Screw Fixation System Bezier Rod?

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

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

The FDA product code for Swedge™ Pedicle Screw Fixation System Bezier Rod 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: 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 K230482Swedge™ Pedicle Screw Fixation 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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