PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE

Cerclage, Fixation

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pioneer System Gtr(greater Trochanteer Reattachment) Device.

Pre-market Notification Details

Device IDK961267
510k NumberK961267
Device Name:PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
ClassificationCerclage, Fixation
Applicant PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855
ContactBurns Severson
CorrespondentBurns Severson
PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette,  MI  49855
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-04-02
Decision Date1996-06-27
Summary:summary

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