WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION— 510(k) K902538
Substantially Equivalent for Some IndicationsDow Corning Wright
FDA 510(k) clearance K902538 for WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION, Substantially Equivalent for Some Indications on 1990-07-06. Applicant: Dow Corning Wright.
Clearance details
- Applicant
- Dow Corning Wright
- Product code
- Code HRY
- 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 HRY
product code HRY- Injury
- 1,551
- Malfunction
- 2,753
- Total
- 4,304
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.