Velox Anterior Cervical Plate System
510(k) K131521
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK131521 | Date24 Dec 2013 | 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- Withdrawn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 Velox Anterior Cervical Plate System is an orthopedic device classified as an anterior cervical plate for internal fixation. It is designed to provide rigid stabilization of the cervical spine (C2 to C7) through screw-mediated bone contact, serving as an adjunct to spinal fusion procedures in skeletally mature patients. The system incorporates an automatic locking mechanism to secure screws, ensuring consistent fixation angles and reducing the risk of loosening. Its modular design allows for customization based on surgical requirements, including variable and fixed-angle screw options.
This system is supplied sterile and intended for single-use, requiring surgical implantation under direct visualization. It is available in multiple plate lengths to accommodate different cervical spine segments, with self-drilling and self-tapping screws for ease of use. The device is manufactured by SpineCraft, LLC, and holds FDA 510(k) clearance (K131521) under the traditional review pathway, classified under product code KWQ. Storage and handling must adhere to sterile surgical protocols to maintain integrity prior to use.
Other devices from Spinecraft LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Velox Anterior Cervical Plate System used for?
The Velox Anterior Cervical Plate System is designed to provide rigid stabilization of the cervical spine (from C2 to C7) as an adjunct to spinal fusion procedures in skeletally mature patients. It uses screw-mediated bone contact to maintain alignment and support healing during recovery from cervical spine injuries or degenerative conditions.
How is the Velox Anterior Cervical Plate System supplied and prepared for use?
The system is supplied sterile and intended for single-use only. It must be implanted surgically under direct visualization, following sterile surgical protocols to preserve its integrity before use. The modular design allows for customization with variable or fixed-angle screws, depending on the surgical requirements.
Is the Velox Anterior Cervical Plate System reusable or single-use?
The Velox Anterior Cervical Plate System is explicitly designed for single-use only. Its sterile packaging and surgical application ensure it remains uncontaminated for one procedure, adhering to best practices for orthopedic implants.
What plate lengths and screw types are available in the Velox system?
The Velox system offers multiple plate lengths to accommodate different cervical spine segments (C2–C7). Screws are self-drilling and self-tapping for ease of use, and the system includes both variable-angle and fixed-angle screw options to match surgical needs.
How should the Velox Anterior Cervical Plate System be stored before use?
Storage must comply with sterile surgical protocols to maintain the device’s integrity. The packaging should remain unopened and protected from contamination until immediate preoperative use, following manufacturer guidelines for orthopedic implants.