MEDNEXT BUR
Device Facts
| Record ID | K935861 |
|---|---|
| Device Name | MEDNEXT BUR |
| Applicant | Mednext, Inc. |
| Product Code | HBE · Neurology |
| Decision Date | May 3, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4310 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.
