SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM— 510(k) K123723

Substantially Equivalent

Synthes

FDA 510(k) clearance K123723 for SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM, Substantially Equivalent on 2013-09-05. Applicant: Synthes.

Clearance details

Applicant: Synthes
Product code: Code GWO
Advisory panel: Neurology
Date received: 2012-12-04
Decision date: 2013-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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.