ALTIUS OCT SYSTEM— 510(k) K033961

Substantially Equivalent

Interpore Cross Intl.

FDA 510(k) clearance K033961 for ALTIUS OCT SYSTEM, Substantially Equivalent on 2004-04-14. Applicant: Interpore Cross Intl..

Clearance details

Applicant: Interpore Cross Intl.
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2003-12-22
Decision date: 2004-04-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.