Tritium Sternal Cable Plate System

Cerclage, Fixation

Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.)

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) with the FDA for Tritium Sternal Cable Plate System.

Pre-market Notification Details

Device IDK193468
510k NumberK193468
Device Name:Tritium Sternal Cable Plate System
ClassificationCerclage, Fixation
Applicant Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) 375 River Park Circle Marquette,  MI  49855
ContactLinda Busklein
CorrespondentPeter Browne
A&E Medical Corporation 5206 Asbury Road, PO BOX 758 Farmingdale,  NJ  07727
Product CodeJDQ  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-16
Decision Date2020-03-12

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