OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS— 510(k) K031632

Substantially Equivalent

Implant Innovations, Inc.

FDA 510(k) clearance K031632 for OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS, Substantially Equivalent on 2003-09-16. Applicant: Implant Innovations, Inc..

Clearance details

Applicant: Implant Innovations, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 2003-05-27
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

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Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.