PRECICE Plating System

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

NuVasive Specialized Orthopedics, Inc.

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

Pre-market Notification Details

Device IDK192181
501k NumberK192181
Device Name:PRECICE Plating System
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 CodeKTT  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-12
Decision Date2019-11-07

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.