NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM— 510(k) K122049

Name: FDA 510(k) clearance K122049
Creator: U.S. Food and Drug Administration
Published: 2013-04-05

Substantially Equivalent

Kinamed, Inc.

FDA 510(k) clearance K122049 for NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM, Substantially Equivalent on 2013-04-05. Applicant: Kinamed, Inc.. Device class: 2.

Clearance details

Applicant: Kinamed, Inc.
Product code: Code GWO
Device class: Class 2
Regulation: 21 CFR 882.5320
Advisory panel: Neurology
Date received: 2012-07-12
Decision date: 2013-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GWO

product code GWO

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.