CENTURION POCT SYSTEM

Appliance, Fixation, Spinal Interlaminal

ORTHOFIX, INC.

The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Centurion Poct System.

Pre-market Notification Details

Device IDK131833
510k NumberK131833
Device Name:CENTURION POCT SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactJacki Geren
CorrespondentJacki Geren
ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-20
Decision Date2014-01-30
Summary:summary

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