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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 K243381
Device Name Total Wrist Arthroplasty System (TWA)
Applicant
Skeletal Dynamics, Inc.
7300 N Kendall Dr.
Miami,  FL  33156
Applicant Contact Alexandra Rodriguez
Correspondent
Skeletal Dynamics, Inc.
7300 N Kendall Dr.
Miami,  FL  33156
Correspondent Contact Alexandra Rodriguez
Regulation Number888.3800
Classification Product Code
JWJ  
Date Received10/30/2024
Decision Date 11/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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