MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE— 510(k) K990120

Substantially Equivalent

Depuy Ace Medical Co.

FDA 510(k) clearance K990120 for MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE, Substantially Equivalent on 1999-02-01. Applicant: Depuy Ace Medical Co..

Clearance details

Applicant: Depuy Ace Medical Co.
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1999-01-13
Decision date: 1999-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: El Segundo, CA, 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.