Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System— 510(k) K160085

Clearance details

Applicant

Zimmer GmbH

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2016-01-15

Decision date

2016-03-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Winterthur, CH

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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 →