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FDA 510(k)

SternaFuse Fixation System

K-Number: K202914 · 2022-01-26

ApplicantFusion Innovations, LLC
Decision Date2022-01-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SternaFuse Fixation System is a medical device manufactured by Fusion Innovations, LLC. It received FDA 510(k) clearance on 2022-01-26 under approval number K202914. 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 Fixation System?

SternaFuse Fixation System is a medical device that received FDA 510(k) clearance on 2022-01-26. It is manufactured by Fusion Innovations, LLC. The 510(k) number is K202914.

When was SternaFuse Fixation System approved by the FDA?

SternaFuse Fixation System received FDA 510(k) clearance on 2022-01-26, under approval number K202914.

What company makes SternaFuse Fixation System?

SternaFuse Fixation System is manufactured by Fusion Innovations, LLC.

What is the FDA product code for SternaFuse Fixation System?

The FDA product code for SternaFuse 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

K252661SternaFuse Ti 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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