Aequalis PerFORM+ 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 Perform+ Shoulder System.

Pre-market Notification Details

• Device ID: K160975
• 510k Number: K160975
• Device Name: Aequalis PerFORM+ Shoulder System
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437
• Contact: Loucinda Bjorklund
• Correspondent: Loucinda Bjorklund; TORNIER, INC. 10801 Nesbitt Avenue South Bloomington, MN 55437
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-07
• Decision Date: 2016-06-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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