The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Lumbar Interbody Fusion Device System.
| Device ID | K193106 |
| 510k Number | K193106 |
| Device Name: | SpineFrontier Lumbar Interbody Fusion Device System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineFrontier, Inc. 350 Main Street Malden, MA 02148 |
| Contact | Vito Lore |
| Correspondent | Omkar Joglekar SpineFrontier, Inc. 350 Main St, 2nd Floor Malden, MA 02148 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-08 |
| Decision Date | 2020-06-19 |