The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for The Micro Screw System, Micro Screw System Basic.
| Device ID | K201210 |
| 510k Number | K201210 |
| Device Name: | The Micro Screw System, Micro Screw System Basic |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Contact | Simon Göddeke |
| Correspondent | Simon Göddeke Hager & Meisinger GmbH Hansemannstrasse 10 Neuss, DE 41468 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-05 |
| Decision Date | 2021-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E0HM79BMSPL1 | K201210 | 000 |
| E0HM39MSS100401 | K201210 | 000 |
| E0HM39MSS100601 | K201210 | 000 |
| E0HM39MSS100801 | K201210 | 000 |
| E0HM39MSS101001 | K201210 | 000 |
| E0HM39MSS101201 | K201210 | 000 |
| E0HM39MSS101401 | K201210 | 000 |
| E0HM39MSS120401 | K201210 | 000 |
| E0HM39MSS120601 | K201210 | 000 |
| E0HM39MSS120801 | K201210 | 000 |
| E0HM39MSS121001 | K201210 | 000 |
| E0HM39MSS121201 | K201210 | 000 |
| E0HM39MSS121401 | K201210 | 000 |
| E0HM79BMS001 | K201210 | 000 |
| E0HM79BMSBA1 | K201210 | 000 |
| E0HM79BMA021 | K201210 | 000 |