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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Toe, Hemi-, Phalangeal
510(k) Number K102401
Device Name HEMI IMPLANT; MINI HEMI IMPLANT
Applicant
Vilex, Inc.
111 Moffitt St.
Mcminnville,  TN  37110
Applicant Contact SYLVIA SOUTHARD
Correspondent
Vilex, Inc.
111 Moffitt St.
Mcminnville,  TN  37110
Correspondent Contact SYLVIA SOUTHARD
Regulation Number888.3730
Classification Product Code
KWD  
Date Received08/24/2010
Decision Date 07/20/2011
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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