The following data is part of a premarket notification filed by R Tree Innovations with the FDA for Epicage Interbody Fusion Device.
| Device ID | K092901 |
| 510k Number | K092901 |
| Device Name: | EPICAGE INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | R TREE INNOVATIONS 13540 GUILD AVENUE Apple Valley, MN 55124 |
| Contact | Richard Jansen |
| Correspondent | Richard Jansen R TREE INNOVATIONS 13540 GUILD AVENUE 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 | 2009-09-21 |
| Decision Date | 2010-04-28 |
| Summary: | summary |