SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA) PRODUCTS LLC

The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Brainlab Trauma Compatible Instruments.

Pre-market Notification Details

Device IDK111891
510k NumberK111891
Device Name:SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester,  PA  19380
ContactChristopher Hack
CorrespondentChristopher Hack
SYNTHES (USA) PRODUCTS LLC 1303 GOSHEN PARKWAY West Chester,  PA  19380
Product CodeHSB  
Subsequent Product CodeHRS
Subsequent Product CodeKTT
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-05
Decision Date2011-11-28
Summary:summary

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