Cleared Traditional

Dakota ALIF Plate System

K212937 · Precision Spine, Inc. · Orthopedic
Nov 2021
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K212937 is an FDA 510(k) clearance for the Dakota ALIF Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Precision Spine, Inc. (Pear, US). The FDA issued a Cleared decision on November 4, 2021, 50 days after receiving the submission on September 15, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K212937 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2021
Decision Date November 04, 2021
Days to Decision 50 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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