The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalif Anterior Simple.
| Device ID | K200048 |
| 510k Number | K200048 |
| Device Name: | MectaLIF Anterior Simple |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-09 |
| Decision Date | 2020-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030875557 | K200048 | 000 |
| 07630030875540 | K200048 | 000 |
| 07630030875533 | K200048 | 000 |
| 07630030875526 | K200048 | 000 |
| 07630030861116 | K200048 | 000 |