The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Rampart One Lumbar Interbody Fusion Device.
| Device ID | K163670 |
| 510k Number | K163670 |
| Device Name: | Rampart One Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | SPINEOLOGY INC. 7800 3RD STREET N., SUITE 600 St. Paul, MN 55128 |
| Contact | Jacqueline A. Hauge |
| Correspondent | Jacqueline A. Hauge SPINEOLOGY INC. 7800 3RD STREET N., SUITE 600 St. Paul, MN 55128 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-27 |
| Decision Date | 2017-05-08 |
| Summary: | summary |