LEFORTE SYSTEM BONE SCREW— 510(k) K023365

Substantially Equivalent

Jeil Medical Corporation

FDA 510(k) clearance K023365 for LEFORTE SYSTEM BONE SCREW, Substantially Equivalent on 2003-04-18. Applicant: Jeil Medical Corporation.

Clearance details

Applicant: Jeil Medical Corporation
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2002-10-07
Decision date: 2003-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Field, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.