Cleared Traditional

Ozark(tm) Cervical Plate System

K172104 · K2m, Inc. · Orthopedic
Aug 2017
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K172104 is an FDA 510(k) clearance for the Ozark(tm) Cervical Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by K2m, Inc. (Leesburg, US). The FDA issued a Cleared decision on August 23, 2017, 42 days after receiving the submission on July 12, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K172104 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2017
Decision Date August 23, 2017
Days to Decision 42 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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