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FDA 510(k) Applications for Medical Device Product Code "OYK"
FDA 510(k) Number
Applicant
Device Name
Decision Date
K193432
3D Systems
Vantage PSI System
11/09/2020
K241326
3D Systems, Inc.
Cadence Ankle PSI System
08/30/2024
K243174
3D Systems, Inc.
Cadence Ankle PSI System
10/25/2024
K241148
3D Systems, Inc.
Salto Talaris Ankle PSI System
08/30/2024
K243173
3D Systems, Inc.
Salto Talaris Ankle PSI System
10/25/2024
K231585
3D Systems, Inc.
Vantage PSI System
06/30/2023
K223326
Restor3d
Axiom PSR System
03/30/2023
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