AURORA TITANIUM SPINAL ROD SYSTEM— 510(k) K974213
Substantially Equivalent for Some IndicationsUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K974213 for AURORA TITANIUM SPINAL ROD SYSTEM, Substantially Equivalent for Some Indications on 1998-02-04. 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 for Some Indications
- Clearance type
- Traditional
- 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.