AERO-AL LUMBAR CAGE SYSTEM— 510(k) K133328
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K133328 for AERO-AL LUMBAR CAGE SYSTEM, Substantially Equivalent on 2014-05-30. Applicant: Stryker Corporation.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code OVD
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allendale, NJ, US
Adverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
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.