FORZA XP Expandable Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

Orthofix US LLC

The following data is part of a premarket notification filed by Orthofix Us Llc with the FDA for Forza Xp Expandable Spacer System.

Pre-market Notification Details

Device IDK213951
510k NumberK213951
Device Name:FORZA XP Expandable Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Orthofix US LLC 3451 Plano Parkway Lewisville,  TX  75056
ContactNatalia Volosen
CorrespondentNatalia Volosen
Orthofix US LLC 3451 Plano Parkway Lewisville,  TX  75056
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-17
Decision Date2022-01-05

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