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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
510(k) Number K180624
Device Name Guided Growth Plate System Plus
Applicant
Orthofix Srl
Via Delle Nazioni, 9
Bussolengo,  IT 37012
Applicant Contact Gianluca Ricadona
Correspondent
Wagoner Consulting, LLC
Via Delle Nazioni
9
Bussolengo,  IT 37012
Correspondent Contact Gianluca Ricadona
Regulation Number888.3030
Classification Product Code
OBT  
Date Received03/09/2018
Decision Date 05/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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