OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM— 510(k) K081356
Substantially EquivalentMylad Orthopedic Solutions, LLC
FDA 510(k) clearance K081356 for OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM, Substantially Equivalent on 2008-07-09. Applicant: Mylad Orthopedic Solutions, LLC.
Clearance details
- Applicant
- Mylad Orthopedic Solutions, LLC
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mclean, VA, 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.