Firebird Spinal Fixation System

by Orthofix, Inc. 2 variants

510(k) K130932

Firebird Spinal Fixation System is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K130932 on 7 Aug 2013, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 closed

Documents

510(k) K130932↗

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	NumberK130932	Date7 Aug 2013Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K130932

Recalls

1 recall · FDA

- Terminated Z-1749-2015 FDA Class II initiated 18 May 2015
The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

Timeline

2 dated events

7 Aug 2013 Cleared FDA 510(k) K130932
18 May 2015 Recall initiated FDA recalls Z-1749-2015

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K130932
FDA product code: NKB

Device class: Class II
Regulation: 21 CFR Part 888.3070
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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