SYNTHES MIRS

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE

The following data is part of a premarket notification filed by Synthes Spine with the FDA for Synthes Mirs.

Pre-market Notification Details

Device IDK113044
510k NumberK113044
Device Name:SYNTHES MIRS
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester,  PA  19380
ContactHeather Guerin
CorrespondentHeather Guerin
SYNTHES SPINE 1302 WRIGHTS LN 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 Received2011-10-12
Decision Date2011-12-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H981046315020 K113044 000
H981046517100 K113044 000
H981046517200 K113044 000
H981046517300 K113044 000
H981046517400 K113044 000
H981046517500 K113044 000
H981046516100 K113044 000
H981046516200 K113044 000
H981046516300 K113044 000
H981046516400 K113044 000
H981046516500 K113044 000
H981046516600 K113044 000
H981046516700 K113044 000
H981046516800 K113044 000
H981046516900 K113044 000
H981046315000 K113044 000
H981046517000 K113044 000

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