SYNTHES (USA) 2.0MM TITANIUM T-PLATE— 510(k) K072758
Substantially EquivalentSynthes (Usa)
FDA 510(k) clearance K072758 for SYNTHES (USA) 2.0MM TITANIUM T-PLATE, Substantially Equivalent on 2007-12-18. Applicant: Synthes (Usa).
Clearance details
- Applicant
- Synthes (Usa)
- Product code
- Code GWO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
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.