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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K202771
Device Name CD Horizon Spinal System
Applicant
Medtronic
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Raphael McInnis
Correspondent
Medtronic
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Raphael McInnis
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received09/21/2020
Decision Date 10/19/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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