REMEDY Acetabular Cup

Prosthesis, Hip, Hemi-, Femoral, Metal

OsteoRemedies, LLC

The following data is part of a premarket notification filed by Osteoremedies, Llc with the FDA for Remedy Acetabular Cup.

Pre-market Notification Details

Device IDK191981
510k NumberK191981
Device Name:REMEDY Acetabular Cup
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant OsteoRemedies, LLC 6800 Poplar Avenue, #120 Germantown,  TN  38138
ContactEric Stookey
CorrespondentHollace Saas Rhodes
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20005
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductYes
Date Received2019-07-24
Decision Date2019-08-23

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