SKYHAWK INTERBODY FUSION SYSTEM

Intervertebral Fusion Device With Bone Graft, Lumbar

ORTHOFIX INC.

The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Skyhawk Interbody Fusion System.

Pre-market Notification Details

Device IDK140709
510k NumberK140709
Device Name:SKYHAWK INTERBODY FUSION SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactTroy Brooks
CorrespondentTroy Brooks
ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-21
Decision Date2014-05-27
Summary:summary

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