AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM

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

TORNIER

The following data is part of a premarket notification filed by Tornier with the FDA for Aequalis Shoulder Fracture System & Aequalis Shoulder System.

Pre-market Notification Details

• Device ID: K060209
• 510k Number: K060209
• Device Name: AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334
• Contact: Mireille Lemery
• Correspondent: Mireille Lemery; TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-27
• Decision Date: 2006-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700386915123	K060209	000
03700386915116	K060209	000
03700386915109	K060209	000
03700386915093	K060209	000