Cleared Special

Sure Lok Mini Posterior Cervical/Upper Thoracic System

K150851 · Precision Spine, Inc. · Orthopedic
Jun 2015
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K150851 is an FDA 510(k) clearance for the Sure Lok Mini Posterior Cervical/Upper Thoracic System, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on June 4, 2015, 65 days after receiving the submission on March 31, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number K150851 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2015
Decision Date June 04, 2015
Days to Decision 65 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWP — Appliance, Fixation, Spinal Interlaminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3050

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