The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Rampart-t Interbody Fusion System.
| Device ID | K151020 |
| 510k Number | K151020 |
| Device Name: | Rampart-T Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineology, Inc. 7800 3rd Street N. Saint Paul, MN 55128 |
| Contact | Tim Crabtree |
| Correspondent | Karen Roche Spineology, Inc. 7800 3rd Street N. Suite 600 Saint Paul, MN 55128 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-16 |
| Decision Date | 2015-07-22 |
| Summary: | summary |