LAGUNA PEDICLE SCREW SYSTEM

Thoracolumbosacral Pedicle Screw System

PHYGEN, LLC

The following data is part of a premarket notification filed by Phygen, Llc with the FDA for Laguna Pedicle Screw System.

Pre-market Notification Details

Device IDK103748
510k NumberK103748
Device Name:LAGUNA PEDICLE SCREW SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine,  CA  92612
ContactHartmut Loch
CorrespondentHartmut Loch
PHYGEN, LLC 2301 DUPONT DRIVE SUITE 510 Irvine,  CA  92612
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-23
Decision Date2011-03-02
Summary:summary

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