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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
510(k) Number K200718
Device Name Arthrosurface WristMotion Total Wrist Arthroplasty System
Applicant
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Applicant Contact Dawn J. Wilson
Correspondent
Arthrosurface, Inc.
28 Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact Dawn J. Wilson
Regulation Number888.3800
Classification Product Code
JWJ  
Date Received03/19/2020
Decision Date 10/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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