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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 K191380
Device Name Quantum® Total Ankle Prosthesis
Applicant
In2bones Sas
Ecully,  FR 69130
Applicant Contact Morgane Grenier
Correspondent
In2bones USA
6000 Poplar Ave. Suite 115
Memphis,  TN  38119
Correspondent Contact Christine Scifert
Regulation Number888.3110
Classification Product Code
HSN  
Date Received05/23/2019
Decision Date 01/29/2020
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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