MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900
Device Facts
| Record ID | K010361 |
|---|---|
| Device Name | MEDTRONIC PS MEDICAL INVISX CRANIAL FIXATION SYSTEM, MODEL 60100-60900 |
| Applicant | Medtronic PS Medical |
| Product Code | GXR · Neurology |
| Decision Date | May 7, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5250 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A burr hole cover is a plastic or metal device used to cover or plug holes drilled into the skull during surgery and to reattach cranial bone removed during surgery.
