Spinal plating systems : performance criteria for safety and performance based pathway : guidance for industry and Food and Drug Administration staff Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Bone Plates Equipment Design Equipment Safety Spinal Cord Spinal Fusion Materials Testing This guidance provides performance criteria for spinal plating systems in support of the Safety and Performance Based Pathway. Under this framework, submitters (you) planning to submit a 510(k) using the Safety and Performance Based Pathway for spinal plating systems will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices. [Silver Spring, MD] : Center for Devices and Radiological Health, December 11, 2020 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Technical Report Text 1 online resource (1 PDF file (8 pages)). nlm:nlmuid-9918249507806676-pdf 9918249507806676 http://resource.nlm.nih.gov/9918249507806676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0