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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 K191012
Device Name Navigated Pedicle Access Kit
Applicant
Izi Medical Products, LLC
5 Easter Court, Suite J
Owings Mills,  MD  21117
Applicant Contact Qiang Cao
Correspondent
7D Surgical, Inc.
60 Scarsdale Rd., Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Daniel Ziskind
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/16/2019
Decision Date 08/07/2019
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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