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 | K142504 |
| 510k Number | K142504 |
| Device Name: | SpineFrontier Lumbar Interbody Fusion Device System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineFrontier, Inc. 500 Cummings Center, Suite 3500 Beverly, MA 01915 |
| Contact | Manthan Damani |
| Correspondent | Meredith May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-05 |
| Decision Date | 2015-05-13 |
| Summary: | summary |