The following data is part of a premarket notification filed by Medyssey Co., Ltd. with the FDA for Lp Cage.
| Device ID | K110067 |
| 510k Number | K110067 |
| Device Name: | LP CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | MEDYSSEY CO., LTD. 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen MEDYSSEY CO., LTD. 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-04-08 |
| Summary: | summary |