# K033231: Spina System

- Pathway: 510(k) (Traditional)
- Applicant: North American Medical Corp (Nam)
- Decided: Sep 9, 2005 after 704 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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 herniated 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.

Source page: https://510kreport.com/device/K033231
Methodology: https://510kreport.com/methodology