Identity
- Trade Name
- FIREBIRD FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system FDA UDI
- Device Name
- 4.5mm x 35mm Bone Screw, Self-Tapping, Cannulated FDA UDI
- Model / Reference
- 77-8435 FDA UDI
- Description
- 4.5mm x 35mm Bone Screw, Self-Tapping, Cannulated FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18257200074716 FDA UDI
- 510(k) Number
- K122901 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 4.5 Millimeter FDA UDILength — 35 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system
Firebird by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system.
- TIGER Spine System — CORELINK LLC · Class II
- TIGER Spine System — CORELINK LLC · Class II
- TIGER Spine System — CORELINK LLC · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
- 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
Cleared under the same submission
K122901 also covers:
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
- FIREBIRD — Orthofix US LLC
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 b4ee49fd-7ab5-48a2-9d5a-3685dd363f3e 36 fields · synced May 30, 2026