AEQUALIS ASCEND FLEX SHOULDER SYSTEM

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

Tornier SAS

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

Pre-market Notification Details

• Device ID: K122698
• 510k Number: K122698
• Device Name: AEQUALIS ASCEND FLEX SHOULDER SYSTEM
• Classification: Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented
• Applicant: Tornier SAS 10801 Nesbitt Avenue South Bloomington, MN 55437
• Contact: Brahim Hadri
• Correspondent: Brahim Hadri; Tornier SAS 10801 Nesbitt Avenue South Bloomington, MN 55437
• Product Code: KWS
• CFR Regulation Number: 888.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-09-04
• Decision Date: 2013-01-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03700386940019	K122698	000
03700386940170	K122698	000
03700386940187	K122698	000
03700386940194	K122698	000
03700386940200	K122698	000
03700386940217	K122698	000
03700386940224	K122698	000
03700386940231	K122698	000
03700386940248	K122698	000
03700386942518	K122698	000
03700386942532	K122698	000
03700386942549	K122698	000
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03700386942563	K122698	000
03700386940163	K122698	000
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03700386940026	K122698	000
03700386940033	K122698	000
03700386940040	K122698	000
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03700386940088	K122698	000
03700386940095	K122698	000
03700386940101	K122698	000
03700386940118	K122698	000
03700386940125	K122698	000
03700386940132	K122698	000
03700386940149	K122698	000
03700386942570	K122698	000
03700386942587	K122698	000
03700386942754	K122698	000
03700386942761	K122698	000
03700386942778	K122698	000
03700386942785	K122698	000
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03700386942808	K122698	000
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03700386942846	K122698	000
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03700386942860	K122698	000
03700386942877	K122698	000
03700386942747	K122698	000
03700386942730	K122698	000
03700386942594	K122698	000
03700386942600	K122698	000
03700386942617	K122698	000
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03700386942631	K122698	000
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03700386942884	K122698	000