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 - T/plif.
| Device ID | K183447 |
| 510k Number | K183447 |
| Device Name: | EIT Cellular Titanium Lumbar Cage - T/PLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | EIT Emerging Implant Technologies GmbH Eisenbahnstrasse 84 Wurmlingen, DE 78573 |
| Contact | Barbara Wirth |
| Correspondent | Barbara Wirth EIT Emerging Implant Technologies GmbH Eisenbahnstrasse 84 Wurmlingen, DE 78573 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-02-04 |
| Summary: | summary |