The following data is part of a premarket notification filed by Kuros Biosciences Bv with the FDA for Kuros Tlif Cage.
| Device ID | K183092 |
| 510k Number | K183092 |
| Device Name: | Kuros TLIF Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Kuros Biosciences BV Prof. Bronkhorstlaan 10, Building 48 Bilthoven, NL 3723 Mb |
| Contact | Yvonne P. Bovell |
| Correspondent | Tess Van Dam BAAT Medical PRoducts BV Floris Hazemeijerstraat 800 Hengelo, NL 7555 Rj |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-07 |
| Decision Date | 2019-03-08 |