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FDA 510(k)

Firebird SI Navigation System

K-Number: K252088 · 2025-10-31

ApplicantOrthofix US, LLC
Decision Date2025-10-31
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Firebird SI Navigation System is a medical device manufactured by Orthofix US, LLC. It received FDA 510(k) clearance on 2025-10-31 under approval number K252088. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Firebird SI Navigation System?

Firebird SI Navigation System is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Orthofix US, LLC. The 510(k) number is K252088.

When was Firebird SI Navigation System approved by the FDA?

Firebird SI Navigation System received FDA 510(k) clearance on 2025-10-31, under approval number K252088.

What company makes Firebird SI Navigation System?

Firebird SI Navigation System is manufactured by Orthofix US, LLC.

What is the FDA product code for Firebird SI Navigation System?

The FDA product code for Firebird SI Navigation System is OLO.

Related Clinical Trials

NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT07271238 Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures RECRUITING NCT06895187 Catheter Ablation Using a Novel Navigation and Imaging System NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Orthofix US, LLC

K2117123° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System K213951FORZA XP Expandable Spacer System K230252OFIX MIS App PMA P210035Stimulator, bone growth, non-invasive

Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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