Simpliciti Shoulder System

Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained

TORNIER, INC.

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

Pre-market Notification Details

• Device ID: K143552
• 510k Number: K143552
• Device Name: Simpliciti Shoulder System
• Classification: Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained
• 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: PKC
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-15
• Decision Date: 2015-03-04
• Summary: summary

NIH GUDID Devices

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