Cleared Traditional

PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems

K182473 · K2m, Inc. · Orthopedic

Dec 2018

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K182473 is an FDA 510(k) clearance for the PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems, 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 December 12, 2018, 93 days after receiving the submission on September 10, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number	K182473 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2018
Decision Date	December 12, 2018
Days to Decision	93 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF