K213208 is an FDA 510(k) clearance for the Twist Drills. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).
Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on December 23, 2021, 85 days after receiving the submission on September 29, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.
| 510(k) Number | K213208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2021 |
| Decision Date | December 23, 2021 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBE — Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4310 |