Aviator Anterior Cervical Plate (ACP) System

Appliance, Fixation, Spinal Intervertebral Body

Stryker Corporation

The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Aviator Anterior Cervical Plate (acp) System.

Pre-market Notification Details

Device IDK142237
510k NumberK142237
Device Name:Aviator Anterior Cervical Plate (ACP) System
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale,  NJ  07401
ContactSoraya King
CorrespondentSoraya King
Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale,  NJ  07401
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-13
Decision Date2015-01-26
Summary:summary

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