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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K260054
Device Name I.T.S. PRS Phoenix II
Applicant
I.T.S. GmbH
Autal 28
Laßnitzhöhe,  AT 8301
Applicant Contact Florian Grill
Correspondent
Qserve Group US
350 S Main St., Suite 309
Doylestown,  PA  18901
Correspondent Contact Mindy Mccann
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received01/08/2026
Decision Date 04/24/2026
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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