The following data is part of a premarket notification filed by Rubicon Spine, Llc with the FDA for Rubicon Lumbar Interbody Fusion System.
| Device ID | K181030 |
| 510k Number | K181030 |
| Device Name: | Rubicon Lumbar Interbody Fusion System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Rubicon Spine, LLC 2955-B Bee Ridge Road Sarasota, FL 34239 |
| Contact | Mike Boyer |
| Correspondent | Mike Boyer Rubicon Spine, LLC 2955-B Bee Ridge Road Sarasota, FL 34239 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-18 |
| Decision Date | 2018-07-17 |
| Summary: | summary |