510(k) Report

Devices descending from K150125

5 later devices reach Elite Nitinol Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221947Tyber Medical Staple Fixation System (various)Tyber Medical, LLC20220—
+1K193305DynaClip Bone StapleMedShape, Inc.20203—
+2K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+2K220812DynaClip® Bone StapleMedShape, Inc.20222—
+3K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—