MODIFICATION TO CENTAUR SPINAL SYSTEM— 510(k) K001844

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K001844 for MODIFICATION TO CENTAUR SPINAL SYSTEM, Substantially Equivalent on 2000-07-19. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2000-06-19
Decision date: 2000-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.