The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Rampart One Lumbar Interbody Fusion System.
| Device ID | K191091 |
| 510k Number | K191091 |
| Device Name: | Rampart One Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 |
| Contact | Andrew Adams |
| Correspondent | Andrew Adams Spineology, Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-24 |
| Decision Date | 2019-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7404900011 | K191091 | 000 |
| M7404901823 | K191091 | 000 |
| M7404900006 | K191091 | 000 |
| M7404900004 | K191091 | 000 |
| M7404900003 | K191091 | 000 |
| M7404900002 | K191091 | 000 |
| M7404900001 | K191091 | 000 |