Integrity Implants Navigated Instruments— 510(k) K212088

Substantially Equivalent

Integrity Implants, Inc.

FDA 510(k) clearance K212088 for Integrity Implants Navigated Instruments, Substantially Equivalent on 2021-12-23. Applicant: Integrity Implants, Inc..

Clearance details

Applicant: Integrity Implants, Inc.
Product code: Code OLO
Advisory panel: Neurology
Date received: 2021-07-06
Decision date: 2021-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Beach Gardens, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

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.