SYPMHONY™ OCT System

Posterior Cervical Screw System

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Sypmhony™ Oct System.

Pre-market Notification Details

Device IDK192014
510k NumberK192014
Device Name:SYPMHONY™ OCT System
ClassificationPosterior Cervical Screw System
Applicant Medos International SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactSheree Geller
CorrespondentSheree Geller
DePuy Synthes Spine 325 Paramount Drive Raynham,  MA  02767
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2020-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034520247 K192014 000
10705034520230 K192014 000
10705034520223 K192014 000
10705034520216 K192014 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.