PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES

Appliance, Fixation, Spinal Intervertebral Body

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Anterior Cervical Plate Model 24-series.

Pre-market Notification Details

Device IDK100708
510k NumberK100708
Device Name:PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
ContactEmily M Downs
CorrespondentEmily M Downs
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
Product CodeKWQ  
CFR Regulation Number888.3060 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-03-12
Decision Date2010-06-04
Summary:summary

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