PIONEER STERNAL ASSIST IMPLANT SYSTEM

Plate, Fixation, Bone

PIONEER SURGICAL TECHNOLOGY, INC

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc with the FDA for Pioneer Sternal Assist Implant System.

Pre-market Notification Details

Device IDK120016
510k NumberK120016
Device Name:PIONEER STERNAL ASSIST IMPLANT SYSTEM
ClassificationPlate, Fixation, Bone
Applicant PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette,  MI  49855
ContactSarah Mcintyre
CorrespondentSarah Mcintyre
PIONEER SURGICAL TECHNOLOGY, INC 375 RIVER PARK CIRCLE Marquette,  MI  49855
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-03
Decision Date2012-07-26
Summary:summary

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