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The device provides a program of treatments for relief from pain and disability for those patients suffering with low back pain. A treatment will consist of a physician prescribed treatment period on the device and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with hemiated discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

The SPINA SYSTEM CERVICAL also offers a cervical accessory which provides a program of treatments for relief from neck pain associated with herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Spina System Cervical." This document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or comparative effectiveness studies.

The letter focuses on the FDA's determination of substantial equivalence for the device to legally marketed predicate devices, allowing it to be marketed. It outlines regulatory requirements and provides contact information for further guidance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval notice, not a performance study report.

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