510(k) Report

Devices descending from K034027

3 later devices reach KLS Martin 3DX External Distraction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063792Osteomed External Mandibular Distraction SystemOsteomed LP20072—
+2K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+3K230211CranioXpandKLS-Martin L.P.20230—