DEPUY GLOBAL UNITE SHOULDER SYSTEM

Shoulder Prosthesis, Reverse Configuration

DEPUY (IRELAND)

The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Global Unite Shoulder System.

Pre-market Notification Details

• Device ID: K101996
• 510k Number: K101996
• Device Name: DEPUY GLOBAL UNITE SHOULDER SYSTEM
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE
• Contact: Rhonda Myer
• Correspondent: Rhonda Myer; DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE
• Product Code: PHX
• Subsequent Product Code: HSD
• Subsequent Product Code: KWS
• Subsequent Product Code: MBF
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-15
• Decision Date: 2010-12-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295004011	K101996	000
10603295004288	K101996	000
10603295004295	K101996	000
10603295004301	K101996	000
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10603295004844	K101996	000