The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Medyssey Anterior Cervical Fusion Cage.
| Device ID | K132732 |
| 510k Number | K132732 |
| Device Name: | MEDYSSEY ANTERIOR CERVICAL FUSION CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, STE 123 Elk Grove Village, IL 60007 |
| Contact | John Kuczynski |
| Correspondent | John Kuczynski MEDYSSEY USA, INC. 1550 E. HIGGINS ROAD, STE 123 Elk Grove Village, IL 60007 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-07-18 |