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paeon anterior cervical plate system elatus lumbar plate system
Aegis Spine
Summary: The Paeon Anterior Cervical Plate System by Aegis Spine is a medical device used in spinal surgeries to stabilize the cervical spine. It is primarily used by orthopedic and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K223719 ↗
Decision Date
January 11, 2023
Product Code
KWQ
Device Class
Class 2
Evidence
0 studies
The Paeon Anterior Cervical Plate System was cleared through the FDA 510(k) pathway on January 11, 2023. It is manufactured by Aegis Spine and classified as a Class 2 device under product code KWQ.
What It Is
The Paeon Anterior Cervical Plate System is designed to provide stability to the cervical spine during the healing process following surgery. It consists of a plate that is affixed to the anterior aspect of the cervical vertebrae using screws. This system helps maintain proper alignment and support of the cervical spine, facilitating fusion and recovery.
Clinical Applications
This device is commonly used in procedures such as anterior cervical discectomy and fusion (ACDF), where it provides structural support after the removal of a herniated or degenerated disc. It is typically utilized in hospital settings by orthopedic and neurosurgeons. The device is suitable for adult patients requiring cervical spine stabilization due to degenerative disc disease, trauma, or deformity.
Indications for Use
The FDA-cleared indications for this device include stabilization of the cervical spine in patients with conditions such as degenerative disc disease, trauma, or spinal deformities. It is used to support the spine post-surgery to ensure proper healing and alignment.
Practical Considerations
The Paeon Anterior Cervical Plate System is available in various sizes to accommodate different patient anatomies. It is compatible with standard surgical instruments used in spinal procedures. Surgeons should be familiar with the device's application technique to ensure optimal outcomes.
Frequently Asked Questions
What is the Paeon Anterior Cervical Plate System used for?
It is used to stabilize the cervical spine during the healing process after surgery, such as in cases of degenerative disc disease or trauma.
What specialties typically use this device?
Orthopedic and neurosurgeons typically use this device in spinal surgeries.
What are the FDA-cleared indications?
The device is indicated for stabilization of the cervical spine in conditions like degenerative disc disease, trauma, and spinal deformities.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.