The following data is part of a premarket notification filed by Coligne, Ag with the FDA for Trabis.
| Device ID | K173893 |
| 510k Number | K173893 |
| Device Name: | Trabis |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | coLigne, AG Utoquai 43 Zurich, CH Ch 8008 |
| Contact | Robert Lange |
| Correspondent | J. D. Webb The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, TX 78681 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640173167051 | K173893 | 000 |
| 07640173166870 | K173893 | 000 |
| 07640173166863 | K173893 | 000 |
| 07640173166856 | K173893 | 000 |
| 07640173166849 | K173893 | 000 |
| 07640173166832 | K173893 | 000 |
| 07640173166825 | K173893 | 000 |
| 07640173166818 | K173893 | 000 |
| 07640173166801 | K173893 | 000 |
| 07640173166795 | K173893 | 000 |
| 07640173166788 | K173893 | 000 |
| 07640173166771 | K173893 | 000 |
| 07640173166764 | K173893 | 000 |
| 07640173166757 | K173893 | 000 |
| 07640173166740 | K173893 | 000 |
| 07640173166733 | K173893 | 000 |
| 07640173166887 | K173893 | 000 |
| 07640173166894 | K173893 | 000 |
| 07640173167044 | K173893 | 000 |
| 07640173167037 | K173893 | 000 |
| 07640173167020 | K173893 | 000 |
| 07640173167013 | K173893 | 000 |
| 07640173167006 | K173893 | 000 |
| 07640173166993 | K173893 | 000 |
| 07640173166986 | K173893 | 000 |
| 07640173166979 | K173893 | 000 |
| 07640173166962 | K173893 | 000 |
| 07640173166955 | K173893 | 000 |
| 07640173166948 | K173893 | 000 |
| 07640173166931 | K173893 | 000 |
| 07640173166924 | K173893 | 000 |
| 07640173166917 | K173893 | 000 |
| 07640173166900 | K173893 | 000 |
| 07640173166726 | K173893 | 000 |