WHITESIDE ORTHOLOC II METAL BACKED PATELLA— 510(k) K864627
Substantially Equivalent for Some IndicationsDow Corning Wright
FDA 510(k) clearance K864627 for WHITESIDE ORTHOLOC II METAL BACKED PATELLA, Substantially Equivalent for Some Indications on 1987-02-04. Applicant: Dow Corning Wright.
Clearance details
- Applicant
- Dow Corning Wright
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Arlington, 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.