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510(k) K220216

C-Stem AMT LE Prosthesis by Depuy Ireland UC — Product Code JDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2022
Date Received
January 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type

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