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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K192281
Device Name AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal Syste
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Sergio M. Cordeiro
Correspondent
DePuy Synthes Spine
325 Paramount Drive
Raynham,  MA  02767
Correspondent Contact Sergio M. Cordeiro
Classification Product Code
MRW  
Subsequent Product Codes
KWQ   NKB   NQW  
Date Received08/22/2019
Decision Date 11/20/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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