Firebird Spinal Fixation System
510(k) K141186
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK141186 | Date2 Jan 2015 | StatusActive |
Official records
- FDA 510(k) database K141186
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NKB
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Firebird Spinal Fixation System is a spinal fixation device classified under the nomenclature category NKB, designed for orthopedic applications. It provides mono- and multi-axial screw configurations, including self-tapping and cannulated options with dual-lead bone screw threads, for secure spinal stabilization in surgical procedures.
This system is intended for use in posterior thoracolumbar surgeries, including degenerative disc disease and deformity corrections. Supplied as a reusable surgical instrument set, it requires sterile handling and proper storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance under K141186, classified as substantially equivalent under traditional review by the Orthopedic (OR) Advisory Committee.