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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Component, Traction, Invasive
510(k) Number K770066
Device Name TIBIAL COMPRESSION FRAM FOR FRACTURES
Applicant
Richard F. Kronner, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Richard F. Kronner, M.D.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3040
Classification Product Code
JEC  
Date Received01/12/1977
Decision Date 03/30/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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