KinematX Total Wrist Arthroplasty System

Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

Extremity Medical, LLC.

The following data is part of a premarket notification filed by Extremity Medical, Llc. with the FDA for Kinematx Total Wrist Arthroplasty System.

Pre-market Notification Details

Device IDK191525
510k NumberK191525
Device Name:KinematX Total Wrist Arthroplasty System
ClassificationProsthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Applicant Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
ContactBrian Smekal
CorrespondentBrian Smekal
Extremity Medical, LLC. 300 Interpace Parkway, Suite 410 Parsippany,  NJ  07054
Product CodeJWJ  
CFR Regulation Number888.3800 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-10
Decision Date2020-03-04

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