REUNION BONE SCREW SYSTEM— 510(k) K951389
Substantially Equivalent for Some IndicationsSmith & Nephew Richards, Inc.
FDA 510(k) clearance K951389 for REUNION BONE SCREW SYSTEM, Substantially Equivalent for Some Indications on 1995-07-24. Applicant: Smith & Nephew Richards, Inc..
Clearance details
- Applicant
- Smith & Nephew Richards, Inc.
- 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.