BIOMET MICROFIXATION NEURO PLATING SYSTEM— 510(k) K121624

Clearance details

Applicant

Biomet Microfixation

Product code

Code GWO

Device class

Class 2

Regulation

21 CFR 882.5320

Advisory panel

Neurology

Date received

2012-06-01

Decision date

2012-10-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Jacksonville, FL, US

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Malfunction

583

Total

583

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 →

• Z-0136-2016 — Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.Class II·Terminated·Biomet Microfixation, LLC·20150806
• Z-0137-2016 — Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.Class II·Terminated·Biomet Microfixation, LLC·20150806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121624.