ADVANTAGE DRIVE SYSTEM
Device Facts
| Record ID | K002523 |
|---|---|
| Device Name | ADVANTAGE DRIVE SYSTEM |
| Applicant | Linvatec Corp. |
| Product Code | HBC · Neurology |
| Decision Date | Oct 6, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4360 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.