Navigated Pedicle Access Kit— 510(k) K191012

Clearance details

Applicant

Izi Medical Products, LLC

Product code

Code OLO

Device class

Class 2

Regulation

21 CFR 882.4560

Advisory panel

Neurology

Date received

2019-04-16

Decision date

2019-08-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Owings Mills, MD, US

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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 →