The following data is part of a premarket notification filed by Spineology Inc. with the FDA for Elite Expandable Interbody Fusion Device.
| Device ID | K162879 |
| 510k Number | K162879 |
| Device Name: | Elite Expandable Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spineology Inc. 7800 3rd Street N., Suite 600 St. Paul, MN 55127 |
| Contact | Jacqueline A. Hauge |
| Correspondent | Jacqueline A. Hauge Spineology Inc. 7800 3rd Street N., Suite 600 St. Paul, MN 55127 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-14 |
| Decision Date | 2017-01-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M7401001054 | K162879 | 000 |
| M7401001249 | K162879 | 000 |