SYNTHES PANGEA MONOAXIAL SYSTEM

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE CO.LP

The following data is part of a premarket notification filed by Synthes Spine Co.lp with the FDA for Synthes Pangea Monoaxial System.

Pre-market Notification Details

Device IDK052151
510k NumberK052151
Device Name:SYNTHES PANGEA MONOAXIAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
ContactAngela Mikroulis
CorrespondentAngela Mikroulis
SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST West Chester,  PA  19380
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 Received2005-08-08
Decision Date2005-12-07
Summary:summary

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