Identifiers
- 510(k) Number
- K201979 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cervical Plate System is a medical device designed for use in anterior cervical discectomy and fusion (ACDF) procedures to stabilize the cervical spine. It consists of low-profile titanium plates with a locking mechanism intended to prevent screw backout and provide segmental stabilization from C2 to C7.
The system is supplied as single-level to four-level plates with 14-degree and 18-degree screw angulation options. It is provided in a sterile, single-use configuration and is indicated for use in spinal fusion surgeries. Authorization for this device is based on FDA 510(k) clearance under product code KWQ, with a determination of substantial equivalence.
Frequently asked questions
What is the Cervical Plate System used for?
The Cervical Plate System is designed for use in anterior cervical discectomy and fusion (ACDF) procedures to stabilize the cervical spine, providing segmental stabilization from C2 to C7 levels during spinal fusion surgeries.
How is the Cervical Plate System supplied and is it reusable?
The Cervical Plate System is supplied in a sterile, single-use configuration, meaning each component is intended for one procedure only and should not be reprocessed or reused to maintain sterility and structural integrity.
What screw angulation options are available with the Cervical Plate System?
The system offers 14-degree and 18-degree screw angulation options, allowing surgeons to accommodate anatomical variations and achieve optimal fixation across single-level to four-level cervical plate constructs.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cervical Plate - Eminent Spine, Spinal Products You Can Count On | Eminent Spine, Product-detail | NeuroSpine, Cervical vertebrae - Wikipedia, Cervical Plate Systems | EXALTA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201979 | Class II | Active |
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Manufacturer
- Manufacturer
- Eminent Spine Llc
- FDA Applicant
- Eminent Spine, LLC
Sources (1)
- FDA 510(k) K201979 24 fields · synced Sep 25, 2026