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510(k) K150730

Zimmer PSI Shoulder System by Zimmer — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2015
Date Received
March 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Device Class
Class II
Regulation Number
888.3650
Review Panel
OR
Submission Type

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