U.S. TYPE CRUCIATE SLOT BONE SCREW— 510(k) K905333
Substantially Equivalent for Some IndicationsO'Tec Corp.
FDA 510(k) clearance K905333 for U.S. TYPE CRUCIATE SLOT BONE SCREW, Substantially Equivalent for Some Indications on 1991-01-04. Applicant: O'Tec Corp..
Clearance details
- Applicant
- O'Tec 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.