ASCEND 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 Ascend Shoulder System.

Pre-market Notification Details

• Device ID: K120794
• 510k Number: K120794
• Device Name: ASCEND SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435
• Contact: Brahim Hadri
• Correspondent: Brahim Hadri; TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 Edina, MN 55435
• Product Code: KWS
• Subsequent Product Code: HSD
• Subsequent Product Code: KWT
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-15
• Decision Date: 2012-04-13
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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