The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Rampart(tm) T Lumbar Interbody Fusion Device.
| Device ID | K163409 |
| 510k Number | K163409 |
| Device Name: | Rampart(TM) T Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineology Inc. 7800 3rd Street North, Suite 600 St. Paul, MN 55128 -5455 |
| Contact | Jacqueline A. Hauge |
| Correspondent | Jacqueline A. Hauge Spineology Inc. 7800 3rd Street North, Suite 600 St. Paul, MN 55128 -5455 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-05 |
| Decision Date | 2017-03-08 |
| Summary: | summary |