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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ankle Arthroplasty Implantation System
510(k) Number K241326
Device Name Cadence Ankle PSI System
Applicant
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Applicant Contact Ashley Dawson
Correspondent
3D Systems, Inc.
5381 S. Alkire Cir.
Littleton,  CO  80127
Correspondent Contact Ashley Dawson
Regulation Number888.3110
Classification Product Code
OYK  
Date Received05/10/2024
Decision Date 08/30/2024
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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