DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS— 510(k) K915512
Substantially Equivalent for Some IndicationsPfizer Hospital Products Group, Inc.
FDA 510(k) clearance K915512 for DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS, Substantially Equivalent for Some Indications on 1992-08-18. Applicant: Pfizer Hospital Products Group, Inc..
Clearance details
- Applicant
- Pfizer Hospital Products Group, Inc.
- 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.