SYNTHES USS CONNECTOR

Thoracolumbosacral Pedicle Screw System

SYNTHES SPINE

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

Pre-market Notification Details

Device IDK120571
510k NumberK120571
Device Name:SYNTHES USS CONNECTOR
ClassificationThoracolumbosacral Pedicle Screw System
Applicant SYNTHES SPINE 1302 WRIGHTS LN EAST West Chester,  PA  19380
ContactHemal Mehta
CorrespondentHemal Mehta
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 Received2012-02-27
Decision Date2012-05-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H981046323170 K120571 000
H981046323150 K120571 000
H981046323120 K120571 000

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