ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM— 510(k) K033286

Substantially Equivalent

Orthopedic Designs, Inc. (Odi)

FDA 510(k) clearance K033286 for ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM, Substantially Equivalent on 2004-01-12. Applicant: Orthopedic Designs, Inc. (Odi).

Clearance details

Applicant: Orthopedic Designs, Inc. (Odi)
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2003-10-14
Decision date: 2004-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Petersburg, FL, US

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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.