The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for C7 Anterior Cervical Intervertebral Fusion Cage.
| Device ID | K121320 |
| 510k Number | K121320 |
| Device Name: | C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
| Contact | Michael Kvitnitsky |
| Correspondent | Michael Kvitnitsky MEDYSSEY CO., LTD. 8001 N. LINCOLN AVE SUITE 401 Skokie, IL 60077 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2012-08-10 |
| Summary: | summary |