MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
Device Facts
| Record ID | K900388 |
|---|---|
| Device Name | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES |
| Applicant | Midas Rex Pneumatic Tools, Inc. |
| Product Code | HBE · Neurology |
| Decision Date | May 7, 1990 |
| 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.
