PIONEER LOWTOP SPINAL ROD SYSTEM

Thoracolumbosacral Pedicle Screw System

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer Lowtop Spinal Rod System.

Pre-market Notification Details

Device IDK080504
510k NumberK080504
Device Name:PIONEER LOWTOP SPINAL ROD SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
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 CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-25
Decision Date2008-03-20
Summary:summary

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