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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 K864924
Device Name KIRSCHNER (R) SMALL FRAGMENT FIXATION SYSTEM
Applicant
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/16/1986
Decision Date 03/20/1987
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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