The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Duo™ Lumbar Interbody Fusion Device.
| Device ID | K181792 |
| 510k Number | K181792 |
| Device Name: | Duo™ Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineology Inc. 7800 Third Street N., Suite 600 St. Paul, MN 55128 |
| Contact | Karen Roche |
| Correspondent | Karen Roche Spineology Inc. 7800 Third Street N., Suite 600 St. 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 | 2018-07-05 |
| Decision Date | 2018-08-14 |
| Summary: | summary |