The following data is part of a premarket notification filed by Eli-ka Technologies with the FDA for Mc Bio Supertack Tack 3mm, 4mm And 5mm.
| Device ID | K151540 |
| 510k Number | K151540 |
| Device Name: | MC BIO Supertack Tack 3mm, 4mm And 5mm |
| Classification | Screw, Fixation, Intraosseous |
| Applicant | ELI-KA TECHNOLOGIES 209 MADISON AVE. SUITE-D Monrovia, CA 91016 |
| Contact | Luigi Girotto |
| Correspondent | Luigi Girotto ELI-KA TECHNOLOGIES 209 MADISON AVE. SUITE-D Monrovia, CA 91016 |
| Product Code | DZL |
| CFR Regulation Number | 872.4880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-08 |
| Decision Date | 2016-05-26 |
| Summary: | summary |