opti-Toe— 510(k) K142478
Substantially EquivalentGraham Medical Technologies, LLC (D.B.A.Gramedica)
FDA 510(k) clearance K142478 for opti-Toe, Substantially Equivalent on 2015-05-29. Applicant: Graham Medical Technologies, LLC (D.B.A.Gramedica).
Clearance details
- Applicant
- Graham Medical Technologies, LLC (D.B.A.Gramedica)
- Product code
- Code HTY
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Macomb, MI, US
Adverse events under product code HTY
product code HTY- Injury
- 544
- Total
- 544
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.