The following data is part of a premarket notification filed by Medacta International with the FDA for Mectalif Anterior Stand-alone.
| Device ID | K160605 |
| 510k Number | K160605 |
| Device Name: | MectaLIF Anterior Stand-Alone |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | MEDACTA INTERNATIONAL STRADA REGINA Castel San Pietro, CH Ch 6874 |
| Contact | Michael G. Loiterman |
| Correspondent | Roshana Ahmed MEDACTA USA 2343 Alexandria Drive Lexington, KY 40504 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-02 |
| Decision Date | 2016-07-21 |
| Summary: | summary |