KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED— 510(k) K934589
Substantially Equivalent for Some IndicationsKirschner Medical Corp.
FDA 510(k) clearance K934589 for KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED, Substantially Equivalent for Some Indications on 1994-07-13. Applicant: Kirschner Medical Corp..
Clearance details
- Applicant
- Kirschner Medical Corp.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Fair Lawn, 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.