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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K202552
Device Name Midas Rex Attachments and Dissecting Tools
Applicant
Medtronic Powered Surgical Solutions (Mpss)
4620 N Beach St.
Fort Worth,  TX  76137
Applicant Contact Jainam Shah
Correspondent
Medtronic Powered Surgical Solutions (Mpss)
4620 N Beach St.
Fort Worth,  TX  76137
Correspondent Contact Jainam Shah
Regulation Number882.4560
Classification Product Code
OLO  
Date Received09/03/2020
Decision Date 11/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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