Dental Bone Cutting Instruments

Driver, Wire, And Bone Drill, Manual

SYNTHES (USA) PRODUCTS, LLC

The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Dental Bone Cutting Instruments.

Pre-market Notification Details

Device IDK150796
510k NumberK150796
Device Name:Dental Bone Cutting Instruments
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester,  PA  19380
ContactSusan Lewandowski
CorrespondentSusan Lewandowski
SYNTHES (USA) PRODUCTS, LLC 1301 GOSHEN PARKWAY West Chester,  PA  19380
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-26
Decision Date2015-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H9803112430 K150796 000
H9803108050 K150796 000
H980310800 K150796 000
H980SD3112480 K150796 000
H980SD3112470 K150796 000
H980SD3112460 K150796 000
H980SD3112450 K150796 000
H980SD3112440 K150796 000
H980SD3112430 K150796 000
H679311190 K150796 000
H980310810 K150796 000
H9803108110 K150796 000
H9803108830 K150796 000
H9803112420 K150796 000
H9803112410 K150796 000
H980311240 K150796 000
H980311230 K150796 000
H9803112110 K150796 000
H98031121980 K150796 000
H9803112090 K150796 000
H9803112040 K150796 000
H9803111200 K150796 000
H679311150 K150796 000

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