STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM— 510(k) K033837

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K033837 for STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM, Substantially Equivalent on 2004-01-08. Applicant: Howmedica Osteonics Corp..

Clearance details

Applicant
Howmedica Osteonics Corp.
Product code
Code MQP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Mahwah, NJ, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQP

product code MQP
Injury
372
Malfunction
519
Total
891

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.