AERO-AL LUMBAR CAGE SYSTEM— 510(k) K133328

Substantially Equivalent

Stryker 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
Download summary PDFView on FDA.gov ↗

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.