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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 K211596
Device Name CD Horizon Spinal System
Applicant
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Diamond Wallace
Correspondent
Medtronic
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Diamond Wallace
Regulation Number882.4560
Classification Product Code
OLO  
Date Received05/24/2021
Decision Date 06/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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