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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 K210935
Device Name I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)
Applicant
I.T.S. GmbH
Autal 28
Lassnitzhoehe,  AT 8301
Applicant Contact Florian Grill
Correspondent
Qserve Group, Us, Inc.
350 S. Main St. Suite 309
Doylestown,  PA  18901
Correspondent Contact Jennifer Hadfield
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Codes
HTN   HWC  
Date Received03/29/2021
Decision Date 08/31/2022
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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