The following data is part of a premarket notification filed by Biedermann Motech Gmbh & Co. Kg with the FDA for Telix K Interbody System.
| Device ID | K170890 |
| 510k Number | K170890 |
| Device Name: | TELIX K Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Biedermann Motech GmbH & Co. KG Bertha-von-Suttner-Straße 23 Villingen-schwenningen, DE 78054 |
| Contact | Gerd Federle |
| Correspondent | Gerd Federle Biedermann Motech GmbH & Co. KG Bertha-von-Suttner-Str. 23 Villingen-schwenningen, DE 78054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2017-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250869607872 | K170890 | 000 |
| 04250869607728 | K170890 | 000 |
| 04250869607711 | K170890 | 000 |
| 04250869607704 | K170890 | 000 |
| 04250869607698 | K170890 | 000 |
| 04250869607681 | K170890 | 000 |
| 04250869607674 | K170890 | 000 |
| 04250869607667 | K170890 | 000 |
| 04250869607650 | K170890 | 000 |
| 04250869607643 | K170890 | 000 |
| 04250869607636 | K170890 | 000 |
| 04250869607629 | K170890 | 000 |
| 04250869607735 | K170890 | 000 |
| 04250869607742 | K170890 | 000 |
| 04250869607759 | K170890 | 000 |
| 04250869607865 | K170890 | 000 |
| 04250869607858 | K170890 | 000 |
| 04250869607841 | K170890 | 000 |
| 04250869607834 | K170890 | 000 |
| 04250869607827 | K170890 | 000 |
| 04250869607810 | K170890 | 000 |
| 04250869607803 | K170890 | 000 |
| 04250869607797 | K170890 | 000 |
| 04250869607780 | K170890 | 000 |
| 04250869607773 | K170890 | 000 |
| 04250869607766 | K170890 | 000 |
| 04250869607469 | K170890 | 000 |