NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION— 510(k) K934166
Substantially Equivalent for Some IndicationsCorin Orthopedic Products
FDA 510(k) clearance K934166 for NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION, Substantially Equivalent for Some Indications on 1994-09-07. Applicant: Corin Orthopedic Products.
Clearance details
- Applicant
- Corin Orthopedic Products
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Tampa, FL, 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.