MECTALIF
Intervertebral Fusion Device With Bone Graft, Lumbar
MEDACTA INTERNATIONAL
The following data is part of a premarket notification filed by Medacta International with the FDA for Mectalif.
Pre-market Notification Details
| Device ID | K110927 |
| 510k Number | K110927 |
| Device Name: | MECTALIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Contact | Adam Gross |
| Correspondent | Adam Gross MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-28 |
| Decision Date | 2011-06-13 |
| Summary: | summary |
Trademark Results [MECTALIF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MECTALIF 79093689 4133638 Live/Registered |
MEDACTA INTERNATIONAL S.A. 2010-09-21 |
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