ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW— 510(k) K945687
Substantially Equivalent for Some IndicationsSmith and Nephew Donjoy, Inc.
FDA 510(k) clearance K945687 for ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW, Substantially Equivalent for Some Indications on 1995-06-22. Applicant: Smith and Nephew Donjoy, Inc..
Clearance details
- Applicant
- Smith and Nephew Donjoy, Inc.
- Product code
- Code HWC
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Carsbad, CA, 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.