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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 K243249
Device Name TriALTIS™ Spine System
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Jeanette Gardner
Correspondent
Depuy Synthes Spine
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Jeanette Gardner
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Code
PML  
Date Received10/11/2024
Decision Date 01/17/2025
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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