DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional

Cerclage, Fixation

Synthes (USA) Products LLC/DePuy Orthopaedics Inc

The following data is part of a premarket notification filed by Synthes (usa) Products Llc/depuy Orthopaedics Inc with the FDA for Depuy Synthes (usa) 5.0mm / 7.3mm Crimp Positioning Pins – Mr Conditional, Depuy Synthes Variable Angle Positioning Pins – Mr Conditional, Depuy Synthes Wire Mount – Mr Conditional, Depuy Synthes Cerclage Positioning Pin – Mr Conditional.

Pre-market Notification Details

Device IDK172975
510k NumberK172975
Device Name:DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional
ClassificationCerclage, Fixation
Applicant Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester,  PA  19380
ContactSuchitra Basu
CorrespondentSuchitra Basu
Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester,  PA  19380
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-27
Decision Date2018-06-21
Summary:summary

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