The following data is part of a premarket notification filed by Eit Emerging Implant Technologies Gmbh with the FDA for Eit Cellular Titanium® Lumbar Cage Llif.
Device ID | K181644 |
510k Number | K181644 |
Device Name: | EIT Cellular Titanium® Lumbar Cage LLIF |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | EIT Emerging Implant Technologies GmbH Eisenbahnstrasse 83 Wurmlingen, DE 78573 |
Contact | Barbara Wirth |
Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20005 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-06-22 |
Decision Date | 2018-10-12 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EIT CELLULAR TITANIUM 87789747 not registered Live/Pending |
EIT Emerging Implant Technologies GmbH 2018-02-08 |