MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM)— 510(k) K140462
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K140462 for MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM), Substantially Equivalent on 2014-06-13. Applicant: Synthes (USA) Products, LLC. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code GWO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- West Chester, PA, US
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Adverse events under product code GWO
product code GWO- Malfunction
- 583
- Total
- 583
Source: openFDA MAUDE database, through . 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.