NuVasive AttraX Putty

Filler, Bone Void, Calcium Compound

NuVasive, Incorporated

The following data is part of a premarket notification filed by Nuvasive, Incorporated with the FDA for Nuvasive Attrax Putty.

Pre-market Notification Details

Device IDK191974
501k NumberK191974
Device Name:NuVasive AttraX Putty
ClassificationFiller, Bone Void, Calcium Compound
Applicant NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
ContactJessica Leblanc
CorrespondentJessica Leblanc
NuVasive, Incorporated 7475 Lusk Blvd. San Diego,  CA  92121
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-24
Decision Date2019-11-03

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