POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP.— 510(k) K890132
Substantially Equivalent for Some IndicationsRichards Medical Co., Inc.
FDA 510(k) clearance K890132 for POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP., Substantially Equivalent for Some Indications on 1989-07-19. Applicant: Richards Medical Co., Inc..
Clearance details
- Applicant
- Richards Medical Co., Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Memphis, TN, 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.