PASS OCT Spinal System

Posterior Cervical Screw System

MEDICREA INTERNATIONAL S.A

The following data is part of a premarket notification filed by Medicrea International S.a with the FDA for Pass Oct Spinal System.

Pre-market Notification Details

Device IDK161149
510k NumberK161149
Device Name:PASS OCT Spinal System
ClassificationPosterior Cervical Screw System
Applicant MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron,  FR 01700
ContactDavid Ryan
CorrespondentDavid Ryan
MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron,  FR 01700
Product CodeNKG  
CFR Regulation Number888.3075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-25
Decision Date2016-07-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03613720266808 K161149 000
03613720266792 K161149 000
03613720266785 K161149 000
03613720266778 K161149 000
03613720265016 K161149 000
03613720265009 K161149 000
03613720237068 K161149 000

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