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LaioP3 510(k) Summary for the Spine 360 Cervical Interbody Fusion System 00; y .7 In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for

How to fill out spine 360 cervical interbody

How to fill out spine 360 cervical interbody:

1. Prepare the patient: Prior to the procedure, ensure that the patient is properly positioned and sedated if necessary. This can include aligning the patient's head and neck in the appropriate position for access to the cervical spine.
2. Access the cervical spine: Make a small incision in the front of the neck to gain access to the cervical spine. This is done by carefully dissecting through the layers of tissue, being mindful of any important structures in the area.
3. Prepare the disc space: Use specialized instruments to remove the damaged disc and any remaining cartilage from the disc space. This will create a clear area for the interbody implant.
4. Insert the implant: Choose the appropriate size and type of interbody implant for the patient's specific needs. Gently insert the implant into the disc space, ensuring proper alignment and fit within the surrounding vertebrae.
5. Secure the implant: Depending on the type of implant used, additional steps may be necessary to secure it in place. This can include the use of screws, plates, or other fixation devices to provide stability.
6. Close the incision: Once the implant is securely in place, carefully close the incision using sutures or surgical staples. Apply appropriate dressings to promote healing and prevent infection.

Who needs spine 360 cervical interbody:

1. Individuals with cervical spine degeneration: Spine 360 cervical interbody is commonly recommended for patients with degenerative conditions of the cervical spine, such as cervical disc degeneration or cervical spondylosis.
2. Patients with herniated cervical discs: When non-surgical treatments fail to provide relief, spine 360 cervical interbody may be considered for individuals with herniated discs in the cervical spine. The interbody implant helps to stabilize the affected area and alleviate symptoms.
3. Those with cervical instability or deformity: Spine 360 cervical interbody may also be necessary for patients with cervical instability or deformity, such as those with cervical spine fractures or abnormal curvature of the spine. The interbody implant aids in restoring stability and correcting alignment.

In summary, filling out spine 360 cervical interbody involves preparing the patient, accessing the cervical spine, preparing the disc space, inserting and securing the implant, and closing the incision. This procedure is often recommended for individuals with cervical spine degeneration, herniated cervical discs, or cervical instability or deformity.

For pdfFiller’s FAQs

What is spine 360 cervical interbody?

Spine 360 cervical interbody is a surgical technique used to treat cervical spine conditions by inserting a spacer between vertebrae to promote fusion.

Who is required to file spine 360 cervical interbody?

Surgeons and healthcare providers performing spine 360 cervical interbody procedures are required to file the relevant documentation.

How to fill out spine 360 cervical interbody?

To fill out spine 360 cervical interbody, healthcare providers must provide details of the procedure, patient information, and any complications or outcomes.

What is the purpose of spine 360 cervical interbody?

The purpose of spine 360 cervical interbody is to alleviate pain, stabilize the spine, and improve overall function for patients with cervical spine issues.

What information must be reported on spine 360 cervical interbody?

Information such as the type of procedure, patient demographics, surgical approach, implant used, and post-operative care must be reported on spine 360 cervical interbody.

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