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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K850025
Device Name ORTHOPEDIC IMPLANT PLATES
Applicant
Kirkstil Corp., Inc.
908 Mindy Ln.
St. Louis,  MO  63122
Applicant Contact MADDOX
Correspondent
Kirkstil Corp., Inc.
908 Mindy Ln.
St. Louis,  MO  63122
Correspondent Contact MADDOX
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/03/1985
Decision Date 05/20/1985
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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