510(k) Report

Devices descending from K141106

3 later devices reach Frontier Devices Fusio Screw Fuze System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223819SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20232—
+2K231951SI-Cure Sacroiliac Joint Fusion SystemAlevio, LLC20231—
+3K230226Integrity-SI® Fusion SystemOsteoCentric Technologies20230—