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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
Model SIZES 1, 2, 3, 4, AND 5
Device Name STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
Original Applicant
SKELETAL DYNAMICS, LLC
8905 sw 87 avenue, suite 201
miami,  FL  33176
Original Contact ana m escagedo, esq
Regulation Number888.3770
Classification Product Code
KYI  
Date Received04/18/2011
Decision Date 12/30/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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