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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K820995
Device Name MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
Applicant
LUDEK OPTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LUDEK OPTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3510
Classification Product Code
KRO  
Date Received04/09/1982
Decision Date 05/25/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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