PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL 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 Surgical Technology Quantum Spinal System.

Pre-market Notification Details

Device IDK041167
510k NumberK041167
Device Name:PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL 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 CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-04
Decision Date2004-07-23
Summary:summary

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