SPINE360 Anterior Cervical Plate System
by Spine360
510(k) K092531
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092531 | Date4 Feb 2010 | StatusActive |
Recalls
-
- Terminated Z-0239-2018
Potential incorrect marking and color identification of Piranha screw. Some screws marked as 12 mm actually measure 14 mm.
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- Withdrawn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 Spine360 Anterior Cervical Plate System is a surgical fixation device classified as an Anterior Cervical Plate (FDA Product Code KWQ). It is designed for internal fixation of the cervical spine (C2–C7) to stabilize vertebrae during spinal fusion procedures. The system provides rigid fixation with fixed-angle screws to enhance stability while preserving anterior cervical anatomy. It is intended for use as an adjunct to fusion in degenerative disc disease or other cervical spine pathologies requiring stabilization.
The system is supplied preassembled and includes an anterior plate, self-tapping fixed-angle bone screws, locking shield screws, and locking shields. It is intended for single-use and requires sterile handling in an operating room setting. The device is FDA-cleared under a 510(k) submission (K092531) and is regulated under the Orthopedic advisory committee classification. No additional regulatory markings or MRI safety information are specified.
Other devices from Spine360
Questions
AI-generated answers, 1 Oct 2026
What is the Spine360 Anterior Cervical Plate System used for?
This device is designed for internal fixation of the cervical spine (C2–C7) to stabilize vertebrae during spinal fusion procedures. It is specifically intended as an adjunct to fusion in cases of degenerative disc disease or other cervical spine pathologies requiring stabilization, ensuring rigid fixation while preserving anterior cervical anatomy.
How is the Spine360 Anterior Cervical Plate System supplied?
The system is supplied preassembled and includes an anterior plate, self-tapping fixed-angle bone screws, locking shield screws, and locking shields. This preassembled format simplifies intraoperative setup, reducing preparation time in the operating room.
Is the Spine360 Anterior Cervical Plate System single-use or reusable?
The device is intended for single-use only. This design ensures sterility and reduces the risk of cross-contamination between patients, which is critical in surgical settings where infection control is paramount.
What cervical vertebrae does the Spine360 Anterior Cervical Plate System stabilize?
The system is engineered to stabilize the cervical spine from C2 through C7. This range covers the majority of cervical pathologies requiring anterior fixation, including degenerative changes and trauma-related instability.
How should the Spine360 Anterior Cervical Plate System be stored?
Due to its single-use nature and requirement for sterile handling, the device must be stored in its original packaging in a clean, dry environment protected from moisture, dust, and direct sunlight. Proper storage ensures the integrity of the device until use in the operating room.