The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalif Anterior Stand Alone.
| Device ID | K170455 |
| 510k Number | K170455 |
| Device Name: | MectaLIF Anterior Stand Alone |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Roshana Ahmed Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, KY 40504 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-15 |
| Decision Date | 2017-03-16 |
| Summary: | summary |