SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)

Rod, Fixation, Intramedullary And Accessories

SYNTHES USA

The following data is part of a premarket notification filed by Synthes Usa with the FDA for Set Screw For Ti Trochanteric Fixation Nail(tfn).

Pre-market Notification Details

Device IDK120083
510k NumberK120083
Device Name:SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES USA 1301 GOSHEN PKWY West Chester,  PA  19380
ContactThomas N Shea
CorrespondentThomas N Shea
SYNTHES USA 1301 GOSHEN PKWY West Chester,  PA  19380
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-11
Decision Date2012-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67904032002S0 K120083 000
H67904032001S0 K120083 000
H67904032000S0 K120083 000

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