DURACON STABILIZER FEMORAL COMPONENT AND INSERT— 510(k) K932070
Substantially Equivalent for Some IndicationsHowmedica Corp.
FDA 510(k) clearance K932070 for DURACON STABILIZER FEMORAL COMPONENT AND INSERT, Substantially Equivalent for Some Indications on 1995-03-22. Applicant: Howmedica Corp..
Clearance details
- Applicant
- Howmedica Corp.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Rutherford, NJ, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.