510(k) Report

Devices descending from K240461

2 later devices reach OsteoSinter® EVANS and COTTON wedges and related accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252254Osteotomy Wedge SystemSinaptic Surgical20250—
+1K251791Auxano® Wedge Fixation SystemAuxano Medical, LLC20250—