POROUS COATED GENESIS FEMORAL COMPONENT— 510(k) K885036
Substantially Equivalent for Some IndicationsRichards Medical Co., Inc.
FDA 510(k) clearance K885036 for POROUS COATED GENESIS FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1989-04-19. 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.