← Product Code [ITH](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ITH) · K033231 # SPINA SYSTEM (K033231) _North American Medical Corp (Nam) · ITH · Sep 9, 2005 · Physical Medicine · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ITH/K033231 ## Device Facts - **Applicant:** North American Medical Corp (Nam) - **Product Code:** [ITH](/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ITH.md) - **Decision Date:** Sep 9, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5900 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## 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 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. ## Device Story Spina System Cervical is a power traction device providing static, intermittent, and cycling distraction forces to the spine. Device operates by applying decompression via unloading through distraction and positioning of intervertebral discs. Used in clinical settings under physician prescription to treat pain and disability associated with herniated discs, degenerative disc disease, posterior facet syndrome, and sciatica. System includes a cervical accessory for neck pain relief. Clinicians use the device to deliver programmed treatment sessions; output is the mechanical distraction force applied to the patient to relieve pressure on spinal structures. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and intended use. ## Technological Characteristics Power traction equipment (21 CFR 890.5900). Mechanical distraction system providing static, intermittent, and cycling forces. Includes cervical accessory. Class II device. ## Regulatory Identification Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "U.S. Department of Health and Human Services, Inc." SEP - 9 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Gidgette Rubin Corp V.P./Official Correspondent FDA North American Medical Corporation 3350 Riverwood Parkway, Suite 1900 Atlanta, Georgia 30339 Re: K033231 Trade/Device Name: Spina System Cervical Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: II Product Code: ITH Dated: June 17, 2005 Received: June 17, 2005 Dear Ms. Rubin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ Page 2- Ms. Gidgette Rubin This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter with and on. The FDA finding of substantial equivalence of your device to a legally premarked predicated device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark A. Millman Mark N. Melkerson Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure . {2}------------------------------------------------ ## Indications for Use K033231 510(k) Number (if known): "Spina System Cervical" Device Name: Spina System™/Accu-SPINA™ ( model name pending) Formerly Identified as: 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 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. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ITH/K033231](https://fda.innolitics.com/submissions/PM/subpart-f%E2%80%94physical-medicine-therapeutic-devices/ITH/K033231) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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