The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Roccia Alif, Roccia Tlif.
| Device ID | K180963 |
| 510k Number | K180963 |
| Device Name: | ROCCIA ALIF, ROCCIA TLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Silony Medical GmbH Leinfelder Straße 60 Leinfelden-echterdingen, DE D-70771 |
| Contact | Bircan Tasdelen |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-12 |
| Decision Date | 2018-07-11 |
| Summary: | summary |