Blackstone Spinal Fixation System 4.5MM Mono-Axial Screw
510(k) K013558
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013558 | Date23 Jan 2002 | 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- Withdrawn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
- KWQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3060
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Blackstone Spinal Fixation System 4.5mm Mono-Axial Screw is a spinal fixation device classified as an orthopedic screw for non-cervical spinal applications. It is designed for pedicle screw fixation, providing rigid stabilization to the spine through mono-axial movement constraints. The screw is intended for use in spinal fusion procedures, aiding in the alignment and immobilization of vertebrae. Its mono-axial design restricts rotational movement, enhancing stability during the healing process.
This device is supplied as a reusable component within a spinal fixation system and is intended for surgical use in controlled clinical settings. The 4.5mm screw is part of a larger system that includes rods and connectors, all of which are regulated under FDA 510(k) clearance (K013558). Sterility and single-use specifications are not explicitly stated in the provided data, but it is typically handled as a sterile surgical instrument. The device adheres to orthopedic product standards and is intended for non-cervical spinal applications, as defined by its regulatory submission.