Firebird SI Navigation System

by Orthofix US LLC

510(k) K252088

Firebird SI Navigation System is a Class II device made by Orthofix US LLC, cleared under FDA 510(k) K252088 on 31 Oct 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K252088↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK252088	Date31 Oct 2025Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K252088

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K252088
FDA product code: OLO
FDA applicant: Orthofix US, LLC

Device class: Class II
Regulation: 21 CFR Part 882.4560
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

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