BIOTRACE, MODEL 1730
Device Facts
| Record ID | K002063 |
|---|---|
| Device Name | BIOTRACE, MODEL 1730 |
| Applicant | Bryan Corp. |
| Product Code | MYU · Neurology |
| Decision Date | Aug 10, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5300 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.
