MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI
Device Facts
| Record ID | K861822 |
|---|---|
| Device Name | MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI |
| Applicant | Valley Forge Scientific Corp. |
| Product Code | GWO · Neurology |
| Decision Date | Jul 11, 1986 |
| 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.
