Move Forward 3D Motion Simulation Service

System, Image Processing, Radiological

BIOMET INC.

The following data is part of a premarket notification filed by Biomet Inc. with the FDA for Move Forward 3d Motion Simulation Service.

Pre-market Notification Details

Device IDK162559
510k NumberK162559
Device Name:Move Forward 3D Motion Simulation Service
ClassificationSystem, Image Processing, Radiological
Applicant BIOMET INC. 56 EAST BELL DRIVE Warsaw,  IN  46581
ContactPaul Hardy
CorrespondentPaul Hardy
BIOMET INC. 56 EAST BELL DRIVE Warsaw,  IN  46581
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-14
Decision Date2017-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304992863 K162559 000
00880304990050 K162559 000
00880304990043 K162559 000
00880304990036 K162559 000
00880304990029 K162559 000
00880304990012 K162559 000
00880304990005 K162559 000

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