Guided Growth Plate System Plus

Plate, Bone, Growth Control, Pediatric, Epiphysiodesis

Orthofix Srl

The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Guided Growth Plate System Plus.

Pre-market Notification Details

Device IDK180624
510k NumberK180624
Device Name:Guided Growth Plate System Plus
ClassificationPlate, Bone, Growth Control, Pediatric, Epiphysiodesis
Applicant Orthofix Srl Via Delle Nazioni 9 Bussolengo,  IT 37012
ContactGianluca Ricadona
CorrespondentGianluca Ricadona
Wagoner Consulting LLC Via Delle Nazioni 9 Bussolengo,  IT 37012
Product CodeOBT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-09
Decision Date2018-05-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18054242518396 K180624 000
18054242518389 K180624 000
18054242518372 K180624 000
18054242518242 K180624 000
18054242518235 K180624 000
18054242518228 K180624 000

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