CONSTRUX MINI PEEK TI SPACER SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

ORTHOFIX

The following data is part of a premarket notification filed by Orthofix with the FDA for Construx Mini Peek Ti Spacer System.

Pre-market Notification Details

Device IDK121649
510k NumberK121649
Device Name:CONSTRUX MINI PEEK TI SPACER SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant ORTHOFIX 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactNatalia Volosen
CorrespondentNatalia Volosen
ORTHOFIX 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-05
Decision Date2012-11-29
Summary:summary

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