DUOCENTRIC REVERSED— 510(k) K103251

Substantially Equivalent

Aston Medical

FDA 510(k) clearance K103251 for DUOCENTRIC REVERSED, Substantially Equivalent on 2011-10-28. Applicant: Aston Medical.

Clearance details

Applicant: Aston Medical
Product code: Code PHX
Advisory panel: Orthopedic
Date received: 2010-11-03
Decision date: 2011-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.