PhantomMSK Hip

System, Image Processing, Radiological

OrthoGrid Systems, Inc

The following data is part of a premarket notification filed by Orthogrid Systems, Inc with the FDA for Phantommsk Hip.

Pre-market Notification Details

Device IDK210136
510k NumberK210136
Device Name:PhantomMSK Hip
ClassificationSystem, Image Processing, Radiological
Applicant OrthoGrid Systems, Inc 3865 Wasatch Boulevard Suite 301 Salt Lake City,  UT  84109
ContactTrevor Hafer
CorrespondentTrevor Hafer
OrthoGrid Systems, Inc 3865 Wasatch Boulevard Suite 301 Salt Lake City,  UT  84109
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-02-18

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