Catalyst CSR Shoulder System

Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented

CATALYST ORTHOSCIENCE LLC

The following data is part of a premarket notification filed by Catalyst Orthoscience Llc with the FDA for Catalyst Csr Shoulder System.

Pre-market Notification Details

• Device ID: K152825
• 510k Number: K152825
• Device Name: Catalyst CSR Shoulder System
• Classification: Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
• Applicant: CATALYST ORTHOSCIENCE LLC 5867 WHISPERWOOD CT Naples, FL 34110
• Contact: Stephen Herrington
• Correspondent: Stephen Herrington; CATALYST ORTHOSCIENCE LLC 5867 WHISPERWOOD CT Naples, FL 34110
• Product Code: KWT
• CFR Regulation Number: 888.3650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-29
• Decision Date: 2016-05-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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