U.S. TYPE CRUCIATE SLOT BONE SCREW— 510(k) K903254
Substantially Equivalent for Some IndicationsOnyx Medical Corp.
FDA 510(k) clearance K903254 for U.S. TYPE CRUCIATE SLOT BONE SCREW, Substantially Equivalent for Some Indications on 1990-08-09. Applicant: Onyx Medical Corp..
Clearance details
- Applicant
- Onyx Medical Corp.
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.