AEQUALIS FLEX REVIVE Shoulder System

Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented

Tornier, Inc.

The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Aequalis Flex Revive Shoulder System.

Pre-market Notification Details

• Device ID: K191318
• 510k Number: K191318
• Device Name: AEQUALIS FLEX REVIVE Shoulder System
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55340
• Contact: Katie Molland
• Correspondent: Katie Molland; Tornier, Inc. 10801 Nesbitt Avenue South Bloomington, MN 55340
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: PHX
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-15
• Decision Date: 2019-06-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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