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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shoulder Arthroplasty Implantation System
510(k) Number K243955
Device Name Precision AI Surgical Planning System (PAI-SPS)
Applicant
Precision AI Pty, Ltd.
Address Suite 18, 36 Agnes St.
Fortitude Valley,  AU
Applicant Contact Sara Baniadam
Correspondent
Precision AI Pty, Ltd.
Address Suite 18, 36 Agnes St.
Fortitude Valley,  AU
Correspondent Contact Sara Baniadam
Regulation Number888.3660
Classification Product Code
QHE  
Subsequent Product Codes
KWS   PHX  
Date Received12/23/2024
Decision Date 01/21/2025
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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