HUMERUS WIRES— 510(k) K964243

Substantially Equivalent

Compagnie Financiere & Medicale (Cf&M)

FDA 510(k) clearance K964243 for HUMERUS WIRES, Substantially Equivalent on 1996-12-05. Applicant: Compagnie Financiere & Medicale (Cf&M).

Clearance details

Applicant: Compagnie Financiere & Medicale (Cf&M)
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 1996-10-24
Decision date: 1996-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bourge-En-Bresse, FR

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.