DAC Dynamic Active Compression Plate

Plate, Fixation, Bone

Pioneer Surgical Technology, Inc., DBA RTI Surgical

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc., Dba Rti Surgical with the FDA for Dac Dynamic Active Compression Plate.

Pre-market Notification Details

Device IDK200513
510k NumberK200513
Device Name:DAC Dynamic Active Compression Plate
ClassificationPlate, Fixation, Bone
Applicant Pioneer Surgical Technology, Inc., DBA RTI Surgical 375 River Park Circle Marquette,  MI  49855
ContactLinda Busklein
CorrespondentSarah Pleaugh
Pioneer Surgical Technology, Inc., DBA RTI Surgical 375 River Park Circle Marquette,  MI  49855
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-07-22

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