PRECICE System

Rod, Fixation, Intramedullary And Accessories

NuVasive Specialized Orthopedics, Inc.

The following data is part of a premarket notification filed by Nuvasive Specialized Orthopedics, Inc. with the FDA for Precice System.

Pre-market Notification Details

Device IDK173129
510k NumberK173129
Device Name:PRECICE System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo,  CA  92656
ContactLance Justice
CorrespondentLance Justice
NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo,  CA  92656
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-12-01
Summary:summary

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