E-MATRIX GRAFT BONE EXTENDER

Filler, Bone Void, Calcium Compound

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for E-matrix Graft Bone Extender.

Pre-market Notification Details

Device IDK083449
510k NumberK083449
Device Name:E-MATRIX GRAFT BONE EXTENDER
ClassificationFiller, Bone Void, Calcium Compound
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855 -0627
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-11-21
Decision Date2009-06-12
Summary:summary

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