ROGOZINSKI SPINAL ROD SYSTEM— 510(k) K983904
Substantially EquivalentUnited States Surgical, A Division of Tyco Healthc
FDA 510(k) clearance K983904 for ROGOZINSKI SPINAL ROD SYSTEM, Substantially Equivalent on 1998-12-22. Applicant: United States Surgical, A Division of Tyco Healthc.
Clearance details
- Applicant
- United States Surgical, A Division of Tyco Healthc
- Product code
- Code KWP
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norwalk, CT, US
Adverse events under product code KWP
product code KWP- Death
- 7
- Injury
- 1,539
- Malfunction
- 1,519
- Total
- 3,065
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.