PROFORM CEMENTED FEMORAL COMPONENT— 510(k) K951083
Substantially Equivalent for Some IndicationsStelkast Company
FDA 510(k) clearance K951083 for PROFORM CEMENTED FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1995-05-22. Applicant: Stelkast Company.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code JDG
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Adverse events under product code JDG
product code JDG- Injury
- 804
- Malfunction
- 3,242
- Total
- 4,046
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.