FDA 510(k) Applications for Medical Device Product Code "OBT"
(Plate, Bone, Growth Control, Pediatric, Epiphysiodesis)

FDA 510(k) Number Applicant Device Name Decision Date
K093442 ORTHOFIX INC. GUIDED GROWTH SYSTEM 06/10/2010
K110805 ORTHOFIX INC. GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL) 06/21/2011
K172183 Orthofix Srl Guided Growth Plate System Plus 01/09/2018
K180624 Orthofix Srl Guided Growth Plate System Plus 05/15/2018
K220190 Pega Medical, Inc. The GIRO Growth Modulation System 10/24/2022
K182704 WishBone Medical WishBone Guided Growth System 06/25/2019


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