510(k) Report

Devices descending from K203595

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260995DynaNail Helix® Fixation SystemMedShape, Inc.20260—
+1K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics20260—
+1K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip…MedShape, Inc.20261—
+1K233567OsteoCoil™ Nitinol Compression System (Multiple Component PNs)Flower Orthopedics Corporation Dba Conventus Flower Ortho20241—
+2K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped20260—