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 IDK182240
510k NumberK182240
Device Name:PASS LP Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Medicrea International S.A. 5389 Route De Strasbourg Rillieux-la-pape,  FR 69140
ContactDavid Ryan
CorrespondentDavid Ryan
Medicrea International S.A. 5389 Route De Strasbourg Rillieux-la-pape,  FR 69140
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-20
Decision Date2018-10-17
Summary:summary

NIH GUDID Devices

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