Lateral Plate System

Appliance, Fixation, Spinal Intervertebral Body

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Lateral Plate System.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M7259076060	K190016	000
M72590031526	K190016	000
M72590031524	K190016	000
M72590031522	K190016	000
M72590031520	K190016	000
M72590031518	K190016	000
M72590031516	K190016	000
M72590021524	K190016	000
M72590021522	K190016	000
M72590021520	K190016	000
M72590021518	K190016	000
M72590021516	K190016	000
M72590011528	K190016	000
M72590011526	K190016	000
M72590011524	K190016	000
M72590011522	K190016	000
M72590011520	K190016	000
M72590011518	K190016	000
M72590031528	K190016	000
M72590041520	K190016	000
M7259076055	K190016	000
M7259076050	K190016	000
M7259076045	K190016	000
M7259076040	K190016	000
M7259076035	K190016	000
M7259076030	K190016	000
M7259076025	K190016	000
M7259075560	K190016	000
M7259075555	K190016	000
M7259075550	K190016	000
M7259075535	K190016	000
M7259075530	K190016	000
M7259075525	K190016	000
M72590041528	K190016	000
M72590041526	K190016	000
M72590041524	K190016	000
M72590041522	K190016	000
M72590011516	K190016	000