Poseidon OCT Spinal Fixation System

Posterior Cervical Screw System

Medyssey USA, Inc.

The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Poseidon Oct Spinal Fixation System.

Pre-market Notification Details

Device IDK161637
510k NumberK161637
Device Name:Poseidon OCT Spinal Fixation System
ClassificationPosterior Cervical Screw System
Applicant Medyssey USA, Inc. 1550 E. Higgins Road, Suite 123 Elk Grove Village,  IL  60007
ContactShawn Kim
CorrespondentRich Jansen, Pharm.d.
Silver Pine Consulting, LLC. 11821 Bramble Cove Drive Fort Myers,  FL  33905
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-06-14
Decision Date2017-01-05
Summary:summary

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