Cervical Interbody and VBR Fusion System
by Sync Surgical 510(k)
Active
510(k) K252219
Overview
The Cervical Interbody and VBR Fusion System is an intervertebral body fusion device designed for spinal stabilization in the cervical spine. It combines interbody cages and vertebral body replacement (VBR) components to facilitate fusion and restore structural integrity. The system is intended for use in surgical procedures requiring segmental support and alignment correction. Its modular design allows for customization to match anatomical requirements, including varying interbody heights and footprints.
This system is supplied sterile and intended for single-use in surgical settings. Components are compatible with MRI environments, adhering to established safety standards for metallic implants. Heights and footprints are standardized to accommodate cervical spine anatomy, with precise sizing available to ensure proper fit and fusion outcomes. The device holds FDA 510(k) clearance under the Traditional pathway, classified under product code ODP for orthopedic applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252219 | Date14 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- ODP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Cervical Interbody and VBR Fusion System used for?
This system is designed for spinal stabilization in the cervical spine, specifically for intervertebral body fusion procedures. It combines interbody cages and vertebral body replacement (VBR) components to provide segmental support, correct alignment, and restore structural integrity during surgery. The modular design allows for customization to match anatomical requirements, ensuring a tailored fit for the cervical spine.
How is the Cervical Interbody and VBR Fusion System supplied?
The system is supplied sterile and intended for single-use in surgical settings. This ensures patient safety by minimizing the risk of infection and maintaining device integrity for one procedure only. The sterile packaging is designed to preserve the device’s condition until use.
Can the components of this system be reused?
No, the Cervical Interbody and VBR Fusion System is explicitly intended for single-use only. Reusing medical devices can compromise sterility and increase infection risks, which is why this system is designed for one-time surgical use. Always follow manufacturer guidelines for proper disposal after use.
What sizes and models are available for the cervical spine?
The system offers standardized heights and footprints tailored to cervical spine anatomy, with precise sizing options to ensure proper fit and optimal fusion outcomes. The modular design allows for flexibility in selecting the appropriate components for each patient’s anatomical requirements, ensuring a customized approach to spinal stabilization.
Is this system compatible with MRI environments?
Yes, the components of the Cervical Interbody and VBR Fusion System adhere to safety standards for metallic implants in MRI environments. This compatibility is important for postoperative imaging, as it allows for MRI scans without interference from the device. Always verify compatibility with your MRI equipment and protocols before use.