Inset Reverse Total Shoulder System— 510(k) K210533

Substantially Equivalent

Shoulder Innovations, Inc.

FDA 510(k) clearance K210533 for Inset Reverse Total Shoulder System, Substantially Equivalent on 2021-08-20. Applicant: Shoulder Innovations, Inc..

Clearance details

Applicant: Shoulder Innovations, Inc.
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2021-02-24
Decision date: 2021-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holland, MI, US

Download summary PDF View on FDA.gov ↗

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.