Salvo® Spine System

Thoracolumbosacral Pedicle Screw System

Spine Wave, Inc.

The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Salvo® Spine System.

Pre-market Notification Details

Device IDK202476
510k NumberK202476
Device Name:Salvo® Spine System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Spine Wave, Inc. Three Enterprise Drive, Suite 210 Shelton,  CT  06484
ContactAmy Noccioli
CorrespondentAmy Noccioli
Spine Wave, Inc. Three Enterprise Drive, Suite 210 Shelton,  CT  06484
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2020-11-05

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