SPIRAL RADIUS 90-D SST SYSTEM— 510(k) K012273
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K012273 for SPIRAL RADIUS 90-D SST SYSTEM, Substantially Equivalent on 2001-08-15. Applicant: United States Surgical, A Division of Tyco Healthc.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- Code MNH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norwalk, CT, US
Adverse events under product code MNH
product code MNH- Injury
- 978
- Malfunction
- 793
- Total
- 1,771
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.