White Pearl Preferred Angle Anterior Cervical Plate
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160522 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 White Pearl Preferred Angle Anterior Cervical Plate is a spinal fixation device classified as an Anterior Cervical Plate (Device Type: KWQ). It is designed for internal fixation of the cervical spine, providing rigid stabilization to facilitate spinal fusion in skeletally mature patients. The plate features adjustable screw angles to accommodate varying cervical anatomy, ensuring secure attachment to vertebrae from C2 to T1. Its primary function is to maintain alignment and promote bony fusion in degenerative or traumatic cervical spine conditions.
This device is supplied sterile and intended for single-use. It is intended for use in the operating room under aseptic conditions by trained surgeons. The plate is manufactured under FDA 510(k) clearance (K160522) and adheres to traditional review standards. No MRI safety information is specified, and storage conditions are not detailed in the provided data. The device is distributed by Osseus Fusion Systems, LLC, based in Dallas, TX.
Frequently asked questions
What is the White Pearl Preferred Angle Anterior Cervical Plate used for?
This device is designed for internal fixation of the cervical spine in skeletally mature patients. It provides rigid stabilization to maintain alignment and facilitate spinal fusion in conditions like degenerative disc disease or traumatic cervical spine injuries. The adjustable screw angles accommodate varying cervical anatomy, ensuring secure attachment to vertebrae from C2 through T1.
How is the White Pearl Preferred Angle Anterior Cervical Plate supplied and intended for use?
The plate is supplied sterile and intended exclusively for single-use in the operating room. It must be used under aseptic conditions by trained surgeons to ensure proper fixation and minimize infection risk.
Is the White Pearl Preferred Angle Anterior Cervical Plate reusable?
No, this device is explicitly intended for single-use only. Reuse could compromise sterility, structural integrity, or patient safety, which is why it is designed as a disposable medical device.
What cervical vertebrae does the White Pearl Preferred Angle Anterior Cervical Plate span?
The plate is engineered to secure vertebrae from C2 (the second cervical vertebra) down to T1 (the first thoracic vertebra). This range allows for stabilization across the cervical spine while accommodating anatomical variations through its adjustable screw angles.
Are there any specific storage instructions for the White Pearl Preferred Angle Anterior Cervical Plate?
The provided data does not specify storage conditions for this device. However, as it is sterile and single-use, it should be stored in its original packaging until use to preserve sterility and prevent contamination.
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: White Pearl ACP - Osseus Fusion Systems, PDF SURGICAL TECHNIQUE GUIDE - osseus.com, PDF SURGICAL TECHNIQUE GUIDE - osseus.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160522 | Class II | Active |
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Manufacturer
- Manufacturer
- Osseus Fusion Systems, LLC
Sources (1)
- FDA 510(k) K160522 24 fields · synced Oct 1, 2026