The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Duo Lumbar Interbody Fusion Device.
| Device ID | K190055 |
| 510k Number | K190055 |
| Device Name: | Duo Lumbar Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-11 |
| Decision Date | 2019-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7408608110 | K190055 | 000 |
| M7401001113 | K190055 | 000 |
| M7408600515 | K190055 | 000 |
| M7408600519 | K190055 | 000 |
| M7408608004 | K190055 | 000 |
| M7408608005 | K190055 | 000 |
| M7408608006 | K190055 | 000 |
| M7408608007 | K190055 | 000 |
| M7408608008 | K190055 | 000 |
| M7408608100 | K190055 | 000 |
| M7408608101 | K190055 | 000 |
| M7408608102 | K190055 | 000 |
| M7408608103 | K190055 | 000 |
| M7408608109 | K190055 | 000 |
| M7401001112 | K190055 | 000 |