The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Lateral Plate System.
| Device ID | K190016 |
| 510k Number | K190016 |
| Device Name: | Lateral Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CoreLink, LLC 2072 Fenton Logistics Park Blvd. St.louis, MO 63026 |
| Contact | Steven Mounts |
| Correspondent | Meredith Lee May Empirical Consulting LLC 4628 Northpark Dr Colorado Springs, CO 80918 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-03 |
| Decision Date | 2019-06-12 |