Vertebron SCP Cervical Plate System
510(k) K062110
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK062110 | Date16 Aug 2006 | 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- Withdrawn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 Vertebron SCP Cervical Plate System is an orthopedic device classified as an anterior cervical plate and screw system for spinal fixation. It is designed to provide temporary stabilization of the cervical spine (C3–C7) during surgical fusion procedures, particularly in cases of degenerative disc disease with discogenic neck pain. The system attaches to vertebral bodies via self-tapping and self-drilling screws, securing a plate to facilitate bone graft integration in the interbody space. Its primary function is to maintain alignment and promote spinal fusion while reducing postoperative motion at the operative site.
This system is supplied as a sterile, single-use medical device intended for surgical use in orthopedic settings. It is regulated under FDA 510(k) clearance (K062110) as substantially equivalent to a predicate device, with approval for anterior interbody fixation in cervical spine procedures. The system includes plates and screws sized for cervical vertebrae, requiring aseptic handling and storage as per manufacturer instructions. No MRI safety information is specified, and the device must be used in accordance with surgical best practices to ensure proper fixation and fusion outcomes.
Other devices from Vertebron, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Vertebron SCP Cervical Plate System used for?
The Vertebron SCP Cervical Plate System is designed for anterior cervical spine stabilization during surgical fusion procedures, specifically for degenerative disc disease causing discogenic neck pain. It attaches to cervical vertebrae (C3–C7) via self-tapping and self-drilling screws to maintain alignment, reduce postoperative motion, and promote bone graft integration in the interbody space. This helps achieve stable spinal fusion while minimizing movement at the operative site.
How is the Vertebron SCP Cervical Plate System supplied and prepared for use?
The system is supplied as a sterile, single-use device, meaning it is pre-packaged and intended for one-time surgical use only. It must be handled under aseptic conditions to prevent contamination. Follow the manufacturer’s instructions for sterilization verification and storage to ensure integrity before use.
Is the device reusable or intended for single-use only?
This system is explicitly designed for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, structural integrity, or clinical outcomes. Adherence to single-use guidelines ensures patient safety and regulatory compliance.
What sizes or models are available for the Vertebron SCP Cervical Plate System?
The system includes plates and screws specifically sized for cervical vertebrae (C3–C7). Exact model variations (e.g., plate lengths, screw diameters) are detailed in the surgical kit packaging, which should be consulted preoperatively. The design accommodates standard cervical anatomy for secure fixation.
How should the device be stored before use?
Store the Vertebron SCP Cervical Plate System in its original, unopened packaging in a clean, dry environment protected from moisture, extreme temperatures, and direct sunlight. Follow the manufacturer’s storage instructions to maintain sterility and prevent degradation of materials. Avoid exposure to chemicals or contaminants.