PASS LP Spinal System

Thoracolumbosacral Pedicle 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 Lp Spinal System.

Pre-market Notification Details

Device IDK153413
510k NumberK153413
Device Name:PASS LP Spinal System
ClassificationThoracolumbosacral Pedicle 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 CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-11-25
Decision Date2016-04-22
Summary:summary

NIH GUDID Devices

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