510(k) K200368— LINK Embrace Shoulder System - Reverse Configuration

Substantially Equivalent

Waldemar Link GmbH & Co. KG

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2020-02-14
Decision date: 2021-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norderstedt, DE

Adverse events under product code PHX

product code PHX

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.