InCore MPJ System

Screw, Fixation, Bone

Nextremity Solutions, Inc.

The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Incore Mpj System.

Pre-market Notification Details

Device IDK200124
510k NumberK200124
Device Name:InCore MPJ System
ClassificationScrew, Fixation, Bone
Applicant Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw,  IN  46580
ContactElise Fox
CorrespondentElise Fox
Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw,  IN  46580
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-21
Decision Date2020-05-13

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