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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 K020554
Device Name MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
Applicant
Kinetikos Medical, Inc.
4329 Graydon Rd.
San Diego,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
Kinetikos Medical, Inc.
4329 Graydon Rd.
San Diego,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number888.3800
Classification Product Code
JWJ  
Date Received02/20/2002
Decision Date 05/03/2002
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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