Firebird Spinal Fixation System, Firebird Side-Loading Body
by Blackstone
510(k) K100044
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100044 | Date4 Feb 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
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- Withdrawn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, including the Firebird Side-Loading Body, is classified as a spinal fixation device designed for posterior, non-cervical pedicle screw applications. It is intended for use in skeletally mature patients as an adjunct to spinal fusion procedures, utilizing autograft or allograft materials. The system features mono- and multi-axial screw configurations with dual-lead bone screw threads, available in self-tapping and cannulated designs.
This device is supplied as a reusable surgical implant and is regulated under FDA 510(k) clearance (K100044) with a Special review classification. It is intended for orthopedic use in spinal stabilization procedures and must be handled and stored according to standard surgical implant protocols. No specific sterility or MRI safety information is provided in the available data.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal procedures is the Firebird Spinal Fixation System intended to support, and who is it designed for?
The Firebird Spinal Fixation System is designed as an adjunct to spinal fusion procedures for skeletally mature patients. It is specifically intended for posterior, non-cervical pedicle screw applications, meaning it is used on the back side of the spine (excluding the neck region) to stabilize vertebrae during fusion surgeries. The system utilizes autograft or allograft materials for bone integration.
Is the Firebird Side-Loading Body reusable or single-use, and how should it be handled?
The Firebird Side-Loading Body is supplied as a reusable surgical implant. Since it is intended for reuse, it must be handled, cleaned, sterilized, and stored according to standard surgical implant protocols to ensure safety and functionality for subsequent procedures. No specific sterility instructions are provided beyond typical implant handling guidelines.
What screw configurations and designs are available for the Firebird Spinal Fixation System?
The Firebird Spinal Fixation System offers mono-axial and multi-axial screw configurations, both featuring dual-lead bone screw threads for enhanced stability. These screws come in self-tapping and cannulated designs, allowing for flexibility in surgical techniques depending on the clinical scenario.
How is the regulatory status of this device determined, and what does that mean for its use?
The Firebird Spinal Fixation System received FDA clearance through a 510(k) submission (K100044) with a Special review classification, determined to be substantially equivalent to a predicate device. This means the device has been evaluated by the FDA and deemed comparable in safety and effectiveness to an existing spinal fixation system, allowing it to be legally marketed and used in the U.S. for its intended orthopedic applications.