Precice® Screws

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® Screws.

Pre-market Notification Details

Device IDK193617
510k NumberK193617
Device Name:Precice® Screws
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  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
Subsequent Product CodeKTT
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-26
Decision Date2020-05-08

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