Sure Lok Mini Posterior Cervical/Upper Thoracic System

Appliance, Fixation, Spinal Interlaminal

PRECISION SPINE, INC.

The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Sure Lok Mini Posterior Cervical/upper Thoracic System.

Pre-market Notification Details

• Device ID: K150851
• 510k Number: K150851
• Device Name: Sure Lok Mini Posterior Cervical/Upper Thoracic System
• Classification: Appliance, Fixation, Spinal Interlaminal
• Applicant: PRECISION SPINE, INC. 2050 EXECUTIVE DRIVE Pearl, MS 39208
• Contact: Michael Dawson
• Correspondent: Meredith May; EMPIRICAL CONSULTING, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Product Code: KWP
• CFR Regulation Number: 888.3050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-31
• Decision Date: 2015-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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