510(k) Report

Devices descending from K122284

6 later devices reach Hoffmann 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd.20190—
+1K173883External Fixation SystemLife Spine, Inc.20180—
+1K172438ARBOR External Fixation SystemGlobus Medical, Inc.20180—
+1K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl201421
+2K153233Galaxy UNYCO SystemOrthofix Srl201611
+3K170146Galaxy UNYCO SystemOrthofix Srl20170—