FDA 510(k) Applications for Medical Device Product Code "PBJ"

FDA 510(k) Number Applicant Device Name Decision Date
K150771 KLS MARTIN L.P. RxG Distraction System 08/27/2015
K163315 KLS Martin LP Internal Distraction - Sterile 05/05/2017
K121304 OSTEOMED OSTEOMED CRANIAL DISTRACTION SYSTEM 08/22/2012
K123885 OSTEOMED LP OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR 06/03/2013
K170818 Synthes USA Products, LLC Craniomaxillofacial Distraction System (CMFD) 12/07/2017


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