CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM

Intervertebral Fusion Device With Bone Graft, Cervical

ORTHOFIX, INC.

The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for Construx Mini Peek; Spacer System, Ti Spacer System, Cervical Stand Alone System.

Pre-market Notification Details

Device IDK142152
510k NumberK142152
Device Name:CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactNatalia Volosen
CorrespondentNatalia Volosen
ORTHOFIX, INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeODP  
Subsequent Product CodeMQP
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-06
Decision Date2015-01-08
Summary:summary

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