The following data is part of a premarket notification filed by Spinal Elements Inc. with the FDA for Spinal Elements' Spinous Process Plate System.
| Device ID | K160465 |
| 510k Number | K160465 |
| Device Name: | Spinal Elements' Spinous Process Plate System |
| Classification | Spinous Process Plate |
| Applicant | Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Contact | Julie Lamothe |
| Correspondent | Julie Lamothe, Ph.d., Mba Spinal Elements Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-07-28 |
| Summary: | summary |