The following data is part of a premarket notification filed by Spinal Elements Inc with the FDA for Spinal Elements Cerclage System.
| Device ID | K180728 |
| 510k Number | K180728 |
| Device Name: | Spinal Elements Cerclage System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| 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 | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-20 |
| Decision Date | 2018-09-06 |
| Summary: | summary |