Firebird

FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name: FIREBIRD FDA UDI
Generic Name: Bone-screw internal spinal fixation system FDA UDI
Device Name: 4.0mm x 30mm Uniplanar Reduction Screw, Self-Tapping FDA UDI
Model / Reference: 51-4330 FDA UDI
Description: 4.0mm x 30mm Uniplanar Reduction Screw, Self-Tapping FDA UDI

Identifiers

Primary DI / UDI-DI: 18257200014811 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4.0 Millimeter FDA UDI
Length — 30 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system

The Firebird Bone-screw internal spinal fixation system is a reliable and effective solution for treating various spinal instabilities or deformities. Designed to provide immobilization and stabilization of spinal segments, this device consists of anchors, interconnection mechanisms, longitudinal members, and/or transverse connectors. As an implantable device, it's ideal for patients seeking a minimally invasive treatment option.

Similar devices

Also classified as Bone-screw internal spinal fixation system.

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TIGER Spine System — CORELINK LLC · Class II
TIGER Spine System — CORELINK LLC · Class II
APEX Spine System — SPINECRAFT LLC · Class II
Amendia — SPINAL ELEMENTS, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Orthofix US LLC

Sources (1)

FDA UDI 7444f8b7-5f42-4228-94de-a85cee853149 35 fields · synced Jul 14, 2026