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FDA 510(k)

SternaFuse Ti Fixation System

K-Number: K252661 · 2025-11-19

ApplicantFusion Innovations, LLC
Decision Date2025-11-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SternaFuse Ti Fixation System is a medical device manufactured by Fusion Innovations, LLC. It received FDA 510(k) clearance on 2025-11-19 under approval number K252661. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SternaFuse Ti Fixation System?

SternaFuse Ti Fixation System is a medical device that received FDA 510(k) clearance on 2025-11-19. It is manufactured by Fusion Innovations, LLC. The 510(k) number is K252661.

When was SternaFuse Ti Fixation System approved by the FDA?

SternaFuse Ti Fixation System received FDA 510(k) clearance on 2025-11-19, under approval number K252661.

What company makes SternaFuse Ti Fixation System?

SternaFuse Ti Fixation System is manufactured by Fusion Innovations, LLC.

What is the FDA product code for SternaFuse Ti Fixation System?

The FDA product code for SternaFuse Ti Fixation System is HRS.

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 NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Fusion Innovations, LLC

K202914SternaFuse Fixation System

Related Devices (Code: HRS)

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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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