TALON DISTALFIX PROXIMAL FEMORAL NAIL— 510(k) K111352
Substantially EquivalentOrthopedic Designs North America, Inc.
FDA 510(k) clearance K111352 for TALON DISTALFIX PROXIMAL FEMORAL NAIL, Substantially Equivalent on 2011-08-22. Applicant: Orthopedic Designs North America, Inc..
Clearance details
- Applicant
- Orthopedic Designs North America, Inc.
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Tampa, FL, US
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, through . 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.