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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 K023684
Device Name CANNULATED METALLIC HEMI TOE IMPLANT, MODELS MPJ241975, MPJ221775, MPJ211675, MPJ191565, MPJ171365
Applicant
Vilex, Inc.
345 Old Curry Hollow Rd.
Pleasant Hills,  PA  15236
Applicant Contact ABRAHAM LAVI
Correspondent
Vilex, Inc.
345 Old Curry Hollow Rd.
Pleasant Hills,  PA  15236
Correspondent Contact ABRAHAM LAVI
Regulation Number888.3730
Classification Product Code
KWD  
Date Received11/01/2002
Decision Date 03/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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