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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthofix US, LLC. It received FDA 510(k) clearance on 2025-10-31 under 510(k) 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. The listed applicant is Orthofix US, LLC. The 510(k) number is K252088.

When did Firebird SI Navigation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Firebird SI Navigation System?

The FDA 510(k) record lists Orthofix US, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Orthofix US, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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