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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K230313
Device Name QUANTUM Patient Specific Instrumentation (PSI) System
Applicant
In2bones Sas
26 Chemin Du Petit Bois
Ecully,  FR 69130
Applicant Contact Sabina Ahaddad
Correspondent
In2bones USA
6600 Poplar Ave., Suite 115
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Code
OYK  
Date Received02/06/2023
Decision Date 04/06/2023
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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