AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS— 510(k) K131231

Clearance details

Applicant

Tornier S.A.S.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2013-04-30

Decision date

2013-10-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montbonnot-Saint-Martin, FR

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

Death

10

Injury

9,705

Malfunction

1,252

Total

10,967

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 →