DARWIN KNEE SYSTEM (TC3)— 510(k) K952830
Substantially Equivalent for Some IndicationsJohnson & Johnson Professionals, Inc.
FDA 510(k) clearance K952830 for DARWIN KNEE SYSTEM (TC3), Substantially Equivalent for Some Indications on 1996-01-18. Applicant: Johnson & Johnson Professionals, Inc..
Clearance details
- Applicant
- Johnson & Johnson Professionals, Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Raritan, 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.