510(k) Report

Devices descending from K063792

2 later devices reach Osteomed External Mandibular Distraction System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP20131—
+2K230211CranioXpandKLS-Martin L.P.20230—