Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis— 510(k) K151293

Clearance details

Applicant

Tornier S.A.S.

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2015-05-15

Decision date

2015-09-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Monbonnot Saint Martin, FR

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• K190521 — Aequalis Ascend Flex Shoulder System2019-06-12

Death

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →