The following data is part of a premarket notification filed by Hager & Meisinger Gmbh with the FDA for Meisinger Tacs (meisinger Meitac-kit), Meisinger Pins (meisinger Master-pin-control-kit, Basic-kit.
| Device ID | K130682 |
| 510k Number | K130682 |
| Device Name: | MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
| Contact | Wiebke Stolten |
| Correspondent | Wiebke Stolten HAGER & MEISINGER GMBH HANSEMANNSTRASSE 10 Neuss, DE D-41468 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-13 |
| Decision Date | 2013-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E0HM79MT0019 | K130682 | 000 |
| E0HM79BMPBA1 | K130682 | 000 |
| E0HM79BMP001 | K130682 | 000 |
| E0HM36MTAB09 | K130682 | 000 |
| E0HM36BMP0000101 | K130682 | 000 |
| E0HM36BMP000100101 | K130682 | 000 |
| E0HM36BMP000050101 | K130682 | 000 |
| E0HM79BMPPL1 | K130682 | 000 |
| E0HM79BMA031 | K130682 | 000 |