FORZA PTC Spacer System

Intervertebral Fusion Device With Bone Graft, Lumbar

ORTHOFIX INC.

The following data is part of a premarket notification filed by Orthofix Inc. with the FDA for Forza Ptc Spacer System.

Pre-market Notification Details

Device IDK152475
510k NumberK152475
Device Name:FORZA PTC Spacer System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
ContactNatalia Volosen
CorrespondentNatalia Volosen
ORTHOFIX INC. 3451 PLANO PARKWAY Lewisville,  TX  75056
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-31
Decision Date2016-01-14
Summary:summary

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