The following data is part of a premarket notification filed by Silony Medical Gmbh with the FDA for Oyster Acif Cage.
| Device ID | K182608 |
| 510k Number | K182608 |
| Device Name: | Oyster ACIF Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Silony Medical GmbH Leinfelder Straße 60 Leinfelden-echterdingen, DE D-70771 |
| Contact | Bircan Tasdelen |
| Correspondent | Meredith May Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, CO 80918 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-21 |
| Decision Date | 2019-06-13 |