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510(k) K182500

Catalyst CSR Press-Fit Humeral Components by Catalyst Orthoscience, Inc. — Product Code KWT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
September 12, 2018
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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