Cleared Special

Pyrenees Cervical Plate System

K162664 · K2m, Inc. · Orthopedic
Oct 2016
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K162664 is an FDA 510(k) clearance for the Pyrenees 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 October 7, 2016, 11 days after receiving the submission on September 26, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K162664 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2016
Decision Date October 07, 2016
Days to Decision 11 days
Submission Type Special
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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