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

Appliance, Fixation, Spinal Intervertebral Body

K2M Inc.

The following data is part of a premarket notification filed by K2m Inc. with the FDA for Pyrenees Cervical Plate System, Blue Ridge Cervical Plate System, Ozark Cervical Plate System, Cayman Thoracolumbar And Buttress Plate Systems.

Pre-market Notification Details

Device IDK182473
510k NumberK182473
Device Name:PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar And Buttress Plate Systems
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant K2M Inc. 600 Hope Pkwy. SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentKaren E. Warden, Ph.d.
BackRoads Consulting, Inc PO Box 566 Chesterland,  OH  44026
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-10
Decision Date2018-12-12
Summary:summary

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