The following data is part of a premarket notification filed by Medyssey Usa, Inc. with the FDA for Bn Lumbar Cage System.
| Device ID | K140564 |
| 510k Number | K140564 |
| Device Name: | BN LUMBAR CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDYSSEY USA, INC. 11821 BRAMBLE COVE DR. Ft. Myers, FL 33905 |
| Contact | Rich Jansen, Pharm D. |
| Correspondent | Rich Jansen, Pharm D. MEDYSSEY USA, INC. 11821 BRAMBLE COVE DR. Ft. Myers, FL 33905 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-06-05 |
| Summary: | summary |