Response BandLoc Spinal Fixation

Bone Fixation Cerclage, Sublaminar

OrthoPediatrics Corp.

The following data is part of a premarket notification filed by Orthopediatrics Corp. with the FDA for Response Bandloc Spinal Fixation.

Pre-market Notification Details

Device IDK200097
510k NumberK200097
Device Name:Response BandLoc Spinal Fixation
ClassificationBone Fixation Cerclage, Sublaminar
Applicant OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
ContactJackie Jaskula
CorrespondentJackie Jaskula
OrthoPediatrics Corp. 2850 Frontier Drive Warsaw,  IN  46582
Product CodeOWI  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2020-03-16

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