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 |