LEUCADIA PEDICLE SCREW SYSTEM

Orthosis, Spinal Pedicle Fixation

PHYGEN, LLC

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

Pre-market Notification Details

Device IDK103102
510k NumberK103102
Device Name:LEUCADIA PEDICLE SCREW SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
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 CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-20
Decision Date2011-02-08
Summary:summary

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