TITANIUM MESH
Device Facts
| Record ID | K903485 |
|---|---|
| Device Name | TITANIUM MESH |
| Applicant | Ruggles Corp. |
| Product Code | GWO · Neurology |
| Decision Date | Feb 21, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5320 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.
