The following data is part of a premarket notification filed by Eit Emerging Implant Technologies Gmbh with the FDA for Eit Cellular Titanium Cervical Cage, Eit Cellular Titanium Plif Cages, Eit Cellular Titanium Tlif Cages, And Eit Cellular Titanium Alif Cages.
Device ID | K170503 |
510k Number | K170503 |
Device Name: | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, And EIT Cellular Titanium ALIF Cages |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | EIT Emerging Implant Technologies GmbH Eisenbahnstrasse 84 Wurmlingen, DE 78573 |
Contact | Barbara Wirth |
Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, 10th Floor Washington, DC 20001 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-21 |
Decision Date | 2017-07-11 |
Summary: | summary |