The following data is part of a premarket notification filed by Medacta International, Sa with the FDA for Mectalif Transforaminal.
| Device ID | K120024 |
| 510k Number | K120024 |
| Device Name: | MECTALIF TRANSFORAMINAL |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL UNIT B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL, SA 4725 CALLE QUETZAL UNIT B Camarillo, CA 93012 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-02-28 |
| Summary: | summary |