The following data is part of a premarket notification filed by Biomet Microfixation with the FDA for Twist Drills.
| Device ID | K213208 |
| 510k Number | K213208 |
| Device Name: | Twist Drills |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | Biomet Microfixation 1520 Tradeport Drive Jacksonville, FL 32218 |
| Contact | Mark Wladkowski |
| Correspondent | Danielle Besal MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, CO 80112 |
| Product Code | HBE |
| Subsequent Product Code | DZI |
| Subsequent Product Code | GFG |
| Subsequent Product Code | HBG |
| Subsequent Product Code | HTW |
| Subsequent Product Code | HTZ |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-29 |
| Decision Date | 2021-12-23 |