HALF DOME Posterior Lumbar Interbody System— 510(k) K182877

Clearance details

Applicant

Astura Medical, LLC

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2018-10-15

Decision date

2019-05-03

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

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Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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 →