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FDA 510(k)

KinematX Total Wrist Arthroplasty System

K-Number: K191525 · 2020-03-04

ApplicantExtremity Medical, LLC
Decision Date2020-03-04
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KinematX Total Wrist Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2020-03-04 under 510(k) number K191525. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KinematX Total Wrist Arthroplasty System?

KinematX Total Wrist Arthroplasty System is a medical device that received FDA 510(k) clearance on 2020-03-04. The listed applicant is Extremity Medical, LLC. The 510(k) number is K191525.

When did KinematX Total Wrist Arthroplasty System receive FDA 510(k) clearance?

KinematX Total Wrist Arthroplasty System received FDA 510(k) clearance on 2020-03-04, under 510(k) number K191525.

Who is the listed applicant for KinematX Total Wrist Arthroplasty System?

The FDA 510(k) record lists Extremity Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KinematX Total Wrist Arthroplasty System?

The FDA product code for KinematX Total Wrist Arthroplasty System is JWJ.

Other records listing Extremity Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250536MetaFore Small Screw SystemK251128Extremity Medical External Fixation SystemK241563Extremity Medical External Fixation SystemK212297Omni Foot and Ankle Plating SystemK211261Axis Charcot Fixation SystemK201556Intraosseous Fixation System

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Related Devices (Code: JWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.K233574Total Wrist Arthroplasty System (TWA)Skeletal DynamicsK233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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