PRECIMED TRAUMA SYSTEM— 510(k) K002486

Substantially Equivalent

Patrick Berdoz

FDA 510(k) clearance K002486 for PRECIMED TRAUMA SYSTEM, Substantially Equivalent on 2000-11-09. Applicant: Patrick Berdoz.

Clearance details

Applicant: Patrick Berdoz
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2000-08-14
Decision date: 2000-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chester Springs, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.