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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 K092038
Device Name APTUS K-WIRE SYSTEM
Applicant
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
san diego,  CA  92130
Applicant Contact kevin thomas
Correspondent
MEDARTIS AG
11234 EL CAMINO REAL, STE 200
san diego,  CA  92130
Correspondent Contact kevin thomas
Regulation Number888.3040
Classification Product Code
HTY  
Date Received07/06/2009
Decision Date 09/23/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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