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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name pin, fixation, smooth
510(k) Number K022597
Device Name K-FIX
Original Applicant
9109 copenhaver dr.
potomac,  MD  20854
Original Contact norman f estrin
Regulation Number888.3040
Classification Product Code
Date Received08/05/2002
Decision Date 11/01/2002
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No