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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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