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: K161189
• 510k Number: K161189
• Device Name: Integra TITAN Reverse Shoulder System
• Classification: Shoulder Prosthesis, Reverse Configuration
• Applicant: INTEGRA LIFESCIENCES CORPORATION 8700 CAMERON ROAD, SUITE 100 Austin, TX 78754
• Contact: William Garzon
• Correspondent: William Garzon; INTEGRA LIFESCIENCES CORPORATION 8700 CAMERON ROAD, SUITE 100 Austin, TX 78754
• Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-27
• Decision Date: 2016-08-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556863510	K161189	000