VIPER PRIME™ Screws, VIPER PRIME™ Screws With Fenestrations, EXPEDIUM® Verse Screws With Fenestrations

Thoracolumbosacral Pedicle Screw System

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Viper Prime™ Screws, Viper Prime™ Screws With Fenestrations, Expedium® Verse Screws With Fenestrations.

Pre-market Notification Details

Device IDK173095
510k NumberK173095
Device Name:VIPER PRIME™ Screws, VIPER PRIME™ Screws With Fenestrations, EXPEDIUM® Verse Screws With Fenestrations
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactThao Le
CorrespondentThao Le
DePuy Synthes 325 Paramount Dr. Raynham,  MA  02767
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-29
Decision Date2017-10-25
Summary:summary

Trademark Results [VIPER PRIME]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIPER PRIME
VIPER PRIME
86819099 5464979 Live/Registered
DePuy Synthes, Inc.
2015-11-13

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.