ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM— 510(k) K033878

Substantially Equivalent

Depuy Ace

FDA 510(k) clearance K033878 for ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM, Substantially Equivalent on 2004-02-20. Applicant: Depuy Ace.

Clearance details

Applicant: Depuy Ace
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2003-12-15
Decision date: 2004-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.