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 System.

Pre-market Notification Details

• Device ID: K111902
• 510k Number: K111902
• Device Name: AEQUALIS SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334
• Contact: Severine Bonneton
• Correspondent: Severine Bonneton; TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-05
• Decision Date: 2011-11-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700434019162	K111902	000
03700434021721	K111902	000
03700434021837	K111902	000
03700434021844	K111902	000
03700434021929	K111902	000
03700434021967	K111902	000
03700434022001	K111902	000
03700434022025	K111902	000
03700434022094	K111902	000
03700434022117	K111902	000
03700434022278	K111902	000
03700434022308	K111902	000
03700434022322	K111902	000
03700434022407	K111902	000
03700434022476	K111902	000
03700434022537	K111902	000
03700434022551	K111902	000
03700434021714	K111902	000
03700434021615	K111902	000
03700434019186	K111902	000
03700434019308	K111902	000
03700434019445	K111902	000
03700434019667	K111902	000
03700434019742	K111902	000
03700434019780	K111902	000
03700434020786	K111902	000
03700434020847	K111902	000
03700434020908	K111902	000
03700434021042	K111902	000
03700434021127	K111902	000
03700434021165	K111902	000
03700434021370	K111902	000
03700434021448	K111902	000
03700434021530	K111902	000
03700434021585	K111902	000
03700434022575	K111902	000
03700386937330	K111902	000
03700386937521	K111902	000
03700386937538	K111902	000
03700386937545	K111902	000
03700386937552	K111902	000
03700386937569	K111902	000
03700386937576	K111902	000
03700386937583	K111902	000
03700386937590	K111902	000
03700386937606	K111902	000
03700386937613	K111902	000
03700386937620	K111902	000
03700386937637	K111902	000
03700386937644	K111902	000
03700386937651	K111902	000
03700386937668	K111902	000
03700386937675	K111902	000
03700386937514	K111902	000
03700386937507	K111902	000
03700386937347	K111902	000
03700386937354	K111902	000
03700386937361	K111902	000
03700386937378	K111902	000
03700386937385	K111902	000
03700386937392	K111902	000
03700386937408	K111902	000
03700386937415	K111902	000
03700386937422	K111902	000
03700386937439	K111902	000
03700386937446	K111902	000
03700386937453	K111902	000
03700386937460	K111902	000
03700386937477	K111902	000
03700386937484	K111902	000
03700386937491	K111902	000
03700386937682	K111902	000