SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES

Rod, Fixation, Intramedullary And Accessories

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Trochanteric Fixation Nail (tfn) System, Additional Helical Blades.

Pre-market Notification Details

Device IDK070294
510k NumberK070294
Device Name:SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-31
Decision Date2007-03-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H679456650S0 K070294 000
H679456310S0 K070294 000
H679456300S0 K070294 000

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