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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 K253249
Device Name TriALTIS™ Spine System
Applicant
Medos International SARL
Chemin-Blanc 38
Le Locle,  CH 2400
Applicant Contact Andrew Willwerth
Correspondent
Pioneer Surgical Technologies, Inc.
375 River Park Cir.
Marquette,  MI  49855
Correspondent Contact Sravya Lahari Sripada
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   PML  
Date Received09/29/2025
Decision Date 10/21/2025
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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