Delta Xtend Reverse 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 Delta Xtend Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K183077
• 510k Number: K183077
• Device Name: Delta Xtend Reverse Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork Munster, IE
• Contact: Yayoi Fujimaki
• Correspondent: Yayoi Fujimaki; Depuy Orthopajedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-11-05
• Decision Date: 2019-05-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295507345	K183077	000
10603295502548	K183077	000
10603295502555	K183077	000
10603295502562	K183077	000
10603295502593	K183077	000
10603295502609	K183077	000
10603295502616	K183077	000
10603295502623	K183077	000
10603295502630	K183077	000
10603295502531	K183077	000
10603295502524	K183077	000
10603295502449	K183077	000
10603295502456	K183077	000
10603295502463	K183077	000
10603295502470	K183077	000
10603295502487	K183077	000
10603295502494	K183077	000
10603295502500	K183077	000
10603295502517	K183077	000
10603295502647	K183077	000
10603295507154	K183077	000
10603295507260	K183077	000
10603295507277	K183077	000
10603295507284	K183077	000
10603295507291	K183077	000
10603295507307	K183077	000
10603295507314	K183077	000
10603295507321	K183077	000
10603295507338	K183077	000
10603295507253	K183077	000
10603295507246	K183077	000
10603295507161	K183077	000
10603295507178	K183077	000
10603295507185	K183077	000
10603295507192	K183077	000
10603295507208	K183077	000
10603295507215	K183077	000
10603295507222	K183077	000
10603295507239	K183077	000
10603295502432	K183077	000