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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Fixation Cerclage, Sublaminar
510(k) Number K211057
Device Name LigaPASS® Spinal System, CD Horizon™ Spinal System
Applicant
Medtronic, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Taylor Gold West
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Shweta Sharma
Regulation Number888.3010
Classification Product Code
OWI  
Subsequent Product Codes
KWP   KWQ   NKB  
Date Received04/09/2021
Decision Date 05/27/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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