EVOS Cabling 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 Evos Cabling System.

Pre-market Notification Details

Device IDK201497
510k NumberK201497
Device Name:EVOS Cabling System
ClassificationCerclage, Fixation
Applicant Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette,  MI  49855
ContactSarah Pleaugh
CorrespondentJaclyn Holli
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) 375 River Park Circle Marquette,  MI  49855
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-05
Decision Date2020-10-28

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