FDA 510(k)

Arthrosurface WristMotion Total Wrist Arthroplasty System

K-Number: K200718 · 2020-10-15

Decision Date2020-10-15

Product CodeJWJ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrosurface WristMotion Total Wrist Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2020-10-15 under 510(k) number K200718. 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 Arthrosurface WristMotion Total Wrist Arthroplasty System?

Arthrosurface WristMotion Total Wrist Arthroplasty System is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K200718.

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

Arthrosurface WristMotion Total Wrist Arthroplasty System received FDA 510(k) clearance on 2020-10-15, under 510(k) number K200718.

Who is the listed applicant for Arthrosurface WristMotion Total Wrist Arthroplasty System?

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

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

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

Other records listing Arthrosurface, Inc. 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.

K203375OVOMotion Reverse Shoulder Arthroplasty System K190261BOSS Toe Fixation System K181280Patello-Femoral Wave (Kahuna) Arthroplasty System K173964OVOMotion Shoulder Arthroplasty System K172383Arthrosurface Bone Screws K170440KISSloc Suture System

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Related Devices (Code: JWJ)

K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc.K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, Inc.K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC

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.