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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K021275
Device Name MICOMED POSTERIOR DOUBLEROD SYSTEM
Applicant
Micomed Ortho GmbH
22086 Elsberry Way
Lake Forest,  CA  92630
Applicant Contact CORRINE M TAFLINGER
Correspondent
Micomed Ortho GmbH
22086 Elsberry Way
Lake Forest,  CA  92630
Correspondent Contact CORRINE M TAFLINGER
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
KWP  
Date Received04/22/2002
Decision Date 07/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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