GLOBAL UNITE™ Platform Shoulder System

Shoulder Prosthesis, Reverse Configuration

DePuy Ireland UC

The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Global Unite™ Platform Shoulder System.

Pre-market Notification Details

• Device ID: K202098
• 510k Number: K202098
• Device Name: GLOBAL UNITE™ Platform Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster, IE
• Contact: Karen Mahoney
• Correspondent: Yayoi Fujimaki; DePuy Mitek 325 Paramount Drive Raynham, MA 02767
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-07-29
• Decision Date: 2020-11-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295523383	K202098	000
10603295523376	K202098	000
10603295523369	K202098	000
10603295523352	K202098	000