The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Favo S-tlif.
| Device ID | K190680 |
| 510k Number | K190680 |
| Device Name: | FAVO S-TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen, DE 70771 |
| Contact | Melanie Lubjuhn |
| Correspondent | Melanie Lubjuhn Silony Medical GmbH Leinfelder StraBe 60 Leinfelden-echterdingen, DE 70771 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-18 |
| Decision Date | 2019-07-18 |