THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM— 510(k) K092743
Substantially EquivalentStryker Craniomaxillofacial
FDA 510(k) clearance K092743 for THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM, Substantially Equivalent on 2010-01-15. Applicant: Stryker Craniomaxillofacial.
Clearance details
- Applicant
- Stryker Craniomaxillofacial
- Product code
- Code JEY
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Adverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
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.