510(k) Report

Devices descending from K981362

5 later devices reach Synthes (Usa) External Multi Vector Mandible Distractor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC20190—
+1K063792Osteomed External Mandibular Distraction SystemOsteomed LP20072—
+1K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P.20043—
+2K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+3K230211CranioXpandKLS-Martin L.P.20230—