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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, Carpal Trapezium
510(k) Number K111068
Device Name STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
Applicant
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Applicant Contact ANA M ESCAGEDO, ESQ
Correspondent
Skeletal Dynamics, LLC
8905 SW 87 Ave., Suite 201
Miami,  FL  33176
Correspondent Contact ANA M ESCAGEDO, ESQ
Regulation Number888.3770
Classification Product Code
KYI  
Date Received04/18/2011
Decision Date 12/30/2011
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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