The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Rampart A Lumbar Interbody Fusion Device.
| Device ID | K153082 |
| 510k Number | K153082 |
| Device Name: | Rampart A Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-23 |
| Decision Date | 2016-02-04 |
| Summary: | summary |