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 |