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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 K220724
Device Name CD Horizon™ Spinal System and PASS LP™ Spinal System
Applicant
Medicrea International
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Applicant Contact Karine Trogneux
Correspondent
Medicrea International
5389 Rte. De Strasbourg - Vancia
Rillieux-La-Pape,  FR 69140
Correspondent Contact Karine Trogneux
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received03/14/2022
Decision Date 04/08/2022
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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