EIS THREADED SCREW FRACTURE FIXATION— 510(k) K991964

Substantially Equivalent

Groupe Lepine

FDA 510(k) clearance K991964 for EIS THREADED SCREW FRACTURE FIXATION, Substantially Equivalent on 1999-12-20. Applicant: Groupe Lepine.

Clearance details

Applicant: Groupe Lepine
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 1999-06-10
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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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.