PSL ANTERIOR CERVICAL PLATE SYSTEM

Appliance, Fixation, Spinal Intervertebral Body

PRECISION SURGERY LTD.

The following data is part of a premarket notification filed by Precision Surgery Ltd. with the FDA for Psl Anterior Cervical Plate System.

Pre-market Notification Details

Device IDK103819
510k NumberK103819
Device Name:PSL ANTERIOR CERVICAL PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland,  OH  44026 -2141
ContactKaren E Warden
CorrespondentKaren E Warden
PRECISION SURGERY LTD. 8202 SHERMAN ROAD Chesterland,  OH  44026 -2141
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-30
Decision Date2011-02-15
Summary:summary

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