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Medical Policy Manual Topic: Interspinous Fixation (Fusion) Devices Date of Origin: May 25, 2010, Section: Surgery Last Reviewed Date: December 2015 Policy No: 172 Effective Date: February 1, 2016,

How to fill out interspinous fixation fusion devices

How to fill out interspinous fixation fusion devices:

1. Before starting the procedure, make sure you are wearing sterile gloves and that all necessary equipment is prepared and laid out properly.
2. Begin by positioning the patient on the operating table in the appropriate anatomical position, ensuring their comfort and accessibility to the surgical area.
3. Administer anesthesia to the patient to ensure they are comfortable and pain-free throughout the procedure.
4. Create a small incision in the patient's back, carefully exposing the affected area where the interspinous fixation fusion device will be inserted.
5. Use surgical instruments to carefully remove any damaged or degenerated tissue from the affected area, creating a clean and stable environment for the fusion device.
6. Insert the interspinous fixation fusion device into the prepared area, ensuring proper alignment and placement for optimal effectiveness.
7. Follow the manufacturer's instructions to secure the device in place, typically using screws or other attachment methods.
8. Close the incision meticulously, ensuring proper wound closure techniques are followed to promote healing and minimize the risk of infection.
9. Provide post-operative care and follow-up to the patient, monitoring their progress and providing any necessary pain management or rehabilitation services.

Who needs interspinous fixation fusion devices:

1. Patients suffering from conditions such as spinal stenosis, degenerative disc disease, or other spinal abnormalities that cause pain and instability.
2. Individuals who have exhausted non-surgical treatment options and continue to experience severe symptoms that affect their daily activities and quality of life.
3. Those who have failed to respond to conservative treatments such as physical therapy, medication, and spinal injections and require a more definitive and permanent solution.
4. Patients who have undergone previous spinal surgeries but still experience pain and require additional stabilization and support in the affected area.

For pdfFiller’s FAQs

What is interspinous fixation fusion devices?

Interspinous fixation fusion devices are implants used in spine surgery to stabilize the spine and promote fusion between vertebrae.

Who is required to file interspinous fixation fusion devices?

Manufacturers, distributors, and importers of interspinous fixation fusion devices are required to file with regulatory authorities.

How to fill out interspinous fixation fusion devices?

The filing process for interspinous fixation fusion devices typically involves submitting detailed technical and clinical information to demonstrate safety and efficacy.

What is the purpose of interspinous fixation fusion devices?

The purpose of interspinous fixation fusion devices is to provide stability to the spine and facilitate the fusion of vertebral segments.

What information must be reported on interspinous fixation fusion devices?

Information such as device specifications, materials, design, manufacturing process, clinical data, adverse events, and post-market surveillance data must be reported on interspinous fixation fusion devices.

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