CONSTRUX Mini PEEK 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 Peek Spacer System.

Pre-market Notification Details

Device IDK202949
510k NumberK202949
Device Name:CONSTRUX Mini PEEK 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-30
Decision Date2020-10-29

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