CONSTRUX Mini Ti Spacer 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 Ti Spacer System.

Pre-market Notification Details

Device IDK203342
510k NumberK203342
Device Name:CONSTRUX Mini Ti Spacer 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  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-13
Decision Date2021-03-18

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