PIONEER LUMBAR PLATE SYSTEM

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 Lumbar Plate System.

Pre-market Notification Details

Device IDK090222
510k NumberK090222
Device Name:PIONEER LUMBAR PLATE SYSTEM
ClassificationAppliance, Fixation, Spinal Intervertebral Body
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
ContactJonathan M Gilbert
CorrespondentJonathan M Gilbert
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 Received2009-01-30
Decision Date2009-04-28
Summary:summary

NIH GUDID Devices

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