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510(k) K203230

Global Shoulder and Delta CTA systems by Depuy Lnc. — Product Code KWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2021
Date Received
November 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

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