The following data is part of a premarket notification filed by Spinal Elements Inc. with the FDA for Spinal Elements Ti-bond Coated Devices.
| Device ID | K181837 |
| 510k Number | K181837 |
| Device Name: | Spinal Elements Ti-Bond Coated Devices |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Product Code | MAX |
| Subsequent Product Code | MQP |
| Subsequent Product Code | ODP |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-10 |
| Decision Date | 2018-11-02 |
| Summary: | summary |