Quintex Cervical Plating System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100243 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 Quintex Cervical Plating System is an orthopedic device used for cervical spine fixation. It is designed to provide stabilization in the cervical region of the spine.
The system is supplied as a sterile, single-use device and is available in various sizes. It is intended for use in surgical settings and has received FDA 510(k) clearance with the product code KWQ.
Frequently asked questions
What is the Quintex Cervical Plating System used for?
The Quintex Cervical Plating System is an orthopedic device designed for cervical spine fixation, providing stabilization in the cervical region of the spine during surgical procedures.
How is the Quintex Cervical Plating System supplied?
The system is supplied as a sterile, single-use device and is available in various sizes to accommodate different patient needs and surgical requirements.
What regulatory clearance has the Quintex Cervical Plating System received?
The Quintex Cervical Plating System has received FDA 510(k) clearance with the product code KWQ, classified under the Orthopedic advisory committee.
Is the Quintex Cervical Plating System reusable?
No, the Quintex Cervical Plating System is designed as a single-use device and should not be reused to ensure patient safety and device integrity.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100243 | Class II | Active |
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Manufacturer
- Manufacturer
- Aesculap Implant Systems, Llc
Sources (1)
- FDA 510(k) K100243 24 fields · synced Sep 21, 2026