STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS— 510(k) K032943

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K032943 for STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS, Substantially Equivalent on 2003-12-17. Applicant: Stryker Corp..

Clearance details

Applicant: Stryker Corp.
Product code: Code KNW
Advisory panel: Gastroenterology, Urology
Date received: 2003-09-22
Decision date: 2003-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.