Brisbane ALIF Device, Gladstone ALIF Device— 510(k) K172019

Clearance details

Applicant

Signature Orthopaedics Pty, Ltd.

Product code

Code OVD

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-07-05

Decision date

2017-11-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lane Cove West, AU

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Death

5

Injury

495

Total

500

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 →