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 Alif Cage, Eit Cellular Titanium Tlif Cage, Eit Cellular Titanium Llif Cage, Eit Cellular Titanium T/plif Cage.
| Device ID | K201605 |
| 510k Number | K201605 |
| Device Name: | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EIT Emerging Implant Technologies GmbH Eisenbahnstrasse 84 Wurmlingen, DE 78573 |
| Contact | Barbara Wirth |
| Correspondent | Christine Cahillane DePuy Synthes Spine 325 Paramount Dr. Raynham, MA 02767 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2020-07-15 |