TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE

Drills, Burrs, Trephines & Accessories (simple, Powered)

MEDTRONIC SURGICAL TECHNOLOGIES

The following data is part of a premarket notification filed by Medtronic Surgical Technologies with the FDA for Triton Electric High Torque Handpiece And Software Module.

Pre-market Notification Details

Device IDK121264
510k NumberK121264
Device Name:TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
ClassificationDrills, Burrs, Trephines & Accessories (simple, Powered)
Applicant MEDTRONIC SURGICAL TECHNOLOGIES 4620 NORTH BEACH STREET Fort Worth,  TX  76137
ContactRishi Sinha
CorrespondentRishi Sinha
MEDTRONIC SURGICAL TECHNOLOGIES 4620 NORTH BEACH STREET Fort Worth,  TX  76137
Product CodeHBE  
Subsequent Product CodeHBC
Subsequent Product CodeHRX
Subsequent Product CodeHWE
CFR Regulation Number882.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-04-26
Decision Date2012-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169013155 K121264 000
00643169013148 K121264 000

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