PIONEER STERNAL CABLE PLATE 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 Cable Plate System.

Pre-market Notification Details

Device IDK122293
510k NumberK122293
Device Name:PIONEER STERNAL CABLE PLATE 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  
Subsequent Product CodeHWC
Subsequent Product CodeJDQ
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-31
Decision Date2012-10-12
Summary:summary

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