Integra TITAN Reverse Shoulder System

Shoulder Prosthesis, Reverse Configuration

Integra LifeSciences Corporation

The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Integra Titan Reverse Shoulder System.

Pre-market Notification Details

• Device ID: K190588
• 510k Number: K190588
• Device Name: Integra TITAN Reverse Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: Integra LifeSciences Corporation 11101 Metric Blvd Austin, TX 78758
• Contact: Blesson Abraham
• Correspondent: Blesson Abraham; Integra LifeSciences Corporation 11101 Metric Blvd Austin, TX 78758
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-03-07
• Decision Date: 2019-12-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10381780467601	K190588	000
00885556864128	K190588	000
00885556864135	K190588	000
00885556864142	K190588	000
00885556864159	K190588	000
00885556864166	K190588	000
00885556864173	K190588	000
00885556864104	K190588	000
10381780467533	K190588	000
10381780467540	K190588	000
10381780467557	K190588	000
10381780467564	K190588	000
10381780467571	K190588	000
10381780467588	K190588	000
10381780467595	K190588	000
00885556864111	K190588	000