SYMPHONY™ 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 Symphony™ Oct System.

Pre-market Notification Details

Device IDK181949
510k NumberK181949
Device Name:SYMPHONY™ 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-20
Decision Date2018-10-04
Summary:summary

NIH GUDID Devices

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2022-02-08
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2022-01-11
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97178599 not registered Live/Pending
ANALYZER INC.
2021-12-17
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97032910 not registered Live/Pending
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2021-09-17

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