Stealth-Midas MR8 System

Orthopedic Stereotaxic Instrument

Medtronic Powered Surgical Solutions

The following data is part of a premarket notification filed by Medtronic Powered Surgical Solutions with the FDA for Stealth-midas Mr8 System.

Pre-market Notification Details

Device IDK183644
510k NumberK183644
Device Name:Stealth-Midas MR8 System
ClassificationOrthopedic Stereotaxic Instrument
Applicant Medtronic Powered Surgical Solutions 4620 North Beach Street Fox Worth,  TX  76137
ContactJenna Groves
CorrespondentJenna Groves
Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth,  TX  76137
Product CodeOLO  
Subsequent Product CodeHBB
Subsequent Product CodeHBC
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-26
Decision Date2019-05-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169912205 K183644 000
00643169912168 K183644 000
00643169912151 K183644 000
00763000063979 K183644 000
00763000063337 K183644 000
00763000374730 K183644 000
00763000431020 K183644 000
00763000430924 K183644 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.