The following data is part of a premarket notification filed by Spineology Inc with the FDA for Duo Lumbar Interbody Fusion Device.
| Device ID | K182322 |
| 510k Number | K182322 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-27 |
| Decision Date | 2018-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7401001030 | K182322 | 000 |
| M7401001029 | K182322 | 000 |
| M7401001028 | K182322 | 000 |
| M7401001027 | K182322 | 000 |