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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630030829277 | K120024 | 000 |
| 07630030829109 | K120024 | 000 |
| 07630030829093 | K120024 | 000 |
| 07630030829086 | K120024 | 000 |
| 07630030829079 | K120024 | 000 |
| 07630030829062 | K120024 | 000 |
| 07630030829055 | K120024 | 000 |
| 07630030829048 | K120024 | 000 |
| 07630030829031 | K120024 | 000 |
| 07630030829024 | K120024 | 000 |
| 07630030829017 | K120024 | 000 |
| 07630030829000 | K120024 | 000 |
| 07630030828997 | K120024 | 000 |
| 07630030828980 | K120024 | 000 |
| 07630030828973 | K120024 | 000 |
| 07630030829116 | K120024 | 000 |
| 07630030829123 | K120024 | 000 |
| 07630030829260 | K120024 | 000 |
| 07630030829253 | K120024 | 000 |
| 07630030829246 | K120024 | 000 |
| 07630030829239 | K120024 | 000 |
| 07630030829222 | K120024 | 000 |
| 07630030829215 | K120024 | 000 |
| 07630030829208 | K120024 | 000 |
| 07630030829192 | K120024 | 000 |
| 07630030829185 | K120024 | 000 |
| 07630030829178 | K120024 | 000 |
| 07630030829161 | K120024 | 000 |
| 07630030829154 | K120024 | 000 |
| 07630030829147 | K120024 | 000 |
| 07630030829130 | K120024 | 000 |
| 07630030828966 | K120024 | 000 |