Met One Czar Anterior Cervical Plate System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180772 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 Met One Czar Anterior Cervical Plate System is an orthopedic device classified as an anterior cervical plate (product code KWQ), designed for internal spinal fixation. It provides temporary stabilization of the cervical spine from C2 to T1 during surgical fusion procedures, utilizing titanium and PEEK plates secured with screws to maintain vertebral alignment.
The system is implanted during anterior cervical spine surgery and consists of low-profile (1.9mm) plates and accompanying screws and instruments. Supplied sterile for single-use, it is regulated under FDA 510(k) clearance (K180772) and intended for use in degenerative disc disease, trauma, or spinal stenosis cases. Storage and handling follow standard surgical implant protocols.
Frequently asked questions
What types of spinal conditions is the Met One Czar Anterior Cervical Plate System intended to address during surgery?
The Met One Czar Anterior Cervical Plate System is designed to provide temporary stabilization for patients undergoing surgical fusion procedures in the cervical spine (from C2 to T1). It is specifically intended for cases involving degenerative disc disease, trauma, or spinal stenosis, where maintaining vertebral alignment is critical during the healing process.
Is the Met One Czar Anterior Cervical Plate System reusable, or is it meant for single-use only?
The system is supplied sterile and explicitly labeled for single-use only. This aligns with standard surgical implant protocols to ensure patient safety and sterility, preventing cross-contamination between procedures.
What materials are used in the Met One Czar Anterior Cervical Plate System, and how does this affect its profile?
The system features low-profile titanium and PEEK (polyether ether ketone) plates, which are designed to minimize tissue disruption. The plates have a thickness of just 1.9mm, making them suitable for anterior cervical spine surgeries where a compact profile is advantageous.
How should the Met One Czar Anterior Cervical Plate System be stored to maintain its integrity?
Since it is a sterile, single-use device, storage must follow standard surgical implant protocols to preserve sterility. This typically includes keeping it in its original packaging, away from moisture, extreme temperatures, and direct sunlight, until ready for use in surgery.
What distinguishes the regulatory pathway for the Met One Czar Anterior Cervical Plate System?
The device was cleared through the FDA’s 510(k) process under the traditional review pathway, with a decision code of SESE (Substantially Equivalent in Safety and Effectiveness). It falls under the Orthopedic (OR) advisory committee and is classified under product code KWQ for anterior cervical plates.
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: Met One Czar Anterior Cervical Plate System by Met One Technologies ..., Met One Czar Anterior Cervical Plate System (K180772) — FDA 510 (k ..., Product-detail | NeuroSpine
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180772 | Class II | Active |
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Manufacturer
- Manufacturer
- Met One Technologies
Sources (1)
- FDA 510(k) K180772 24 fields · synced Sep 19, 2026