510(k) Report

Devices descending from K230316

3 later devices reach FlexBand; FlexPatch; FlexBand Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260317Artelon Convenience KitsInternational Life Sciences20260—
+1K242187BioBrace®Conmed Corporation20241—
+2K252946BioBrace® Extra-Articular Ligament Augmentation KitConmed Corporation20250—