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510(k) K152825

Catalyst CSR Shoulder System by Catalyst Orthoscience, LLC — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 2016
Date Received
September 29, 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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  • K182500 — Catalyst CSR Press-Fit Humeral Components (January 11, 2019)

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