Synthes CerviFix System
by Synthes (Usa) 510(k)
Active
510(k) K994187
Overview
The Synthes CerviFix System is a spinal fixation construct comprising rods, plates, hooks, clamps, and bone screws. It is designed for surgical implantation in the cervical and upper thoracic spine (occiput-T3) to promote fusion.
The system is supplied as a set of implants for posterior stabilization of the upper spine, providing flexibility to accommodate variable patient anatomy and the versatility to extend to the occiput and cross the cervicothoracic junction. It is intended for use in surgical settings and is regulated under FDA 510(k) clearance K994187.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK994187 | Date21 Dec 1999 | 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- Withdrawn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
- KWP
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3050
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synthes (Usa)
Questions
What is the Synthes CerviFix System used for?
The Synthes CerviFix System is designed for surgical implantation in the cervical and upper thoracic spine (occiput-T3) to promote fusion, providing posterior stabilization of the upper spine with flexibility to accommodate variable patient anatomy and the versatility to extend to the occiput and cross the cervicothoracic junction.
How is the Synthes CerviFix System supplied?
The system is supplied as a set of implants for posterior stabilization of the upper spine, including rods, plates, hooks, clamps, and bone screws, to provide flexibility and versatility for surgical use in variable anatomies.
Is the Synthes CerviFix System intended for single-use or reuse?
The Synthes CerviFix System is intended for surgical implantation, and as an implantable device, it is designed for single-use in a surgical setting to ensure sterility and patient safety, consistent with standard practice for spinal fixation implants.
What regulatory pathway was used for the Synthes CerviFix System?
The Synthes CerviFix System is regulated under FDA 510(k) clearance K994187, indicating it was cleared through the 510(k) premarket notification process as substantially equivalent to a predicate device.