PRECICE Bone Transport 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 Bone Transport System.

Pre-market Notification Details

Device IDK193016
510k NumberK193016
Device Name:PRECICE Bone Transport System
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant NuVasive Specialized Orthopedics, Inc. 101 Enterprise Suite 100 Aliso Viejo,  CA  92656
ContactMadison Heffron
CorrespondentMadison Heffron
NuVasive Specialized Orthopedics, Inc. 101 Enterprise Suite 100 Aliso Viejo,  CA  92656
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-29
Decision Date2020-05-08

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