3D MAC Titanium Cranial Plate (TCP) System
Device Facts
| Record ID | K253116 |
|---|---|
| Device Name | 3D MAC Titanium Cranial Plate (TCP) System |
| Applicant | The Surgeon General, Department of the Army (TSG-DA) |
| Product Code | GXN · Neurology |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
