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Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff
Bone anchors: premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff
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.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, March 3, 2020
This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This final guidance clarifies and provides current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description. Specifically, this guidance reflects the most current thinking on relevant bench testing methods for bone anchor devices including nitinol and absorbable polymeric bone anchors.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)