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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K024125
Device Name HALM ZIELKE INSTRUMENTATION SYSTEM
Applicant
Micomed Ortho GmbH
13195 Seagrove St.
San Diego,  CA  92130
Applicant Contact CORRINE M BONFIGLIO
Correspondent
Micomed Ortho GmbH
13195 Seagrove St.
San Diego,  CA  92130
Correspondent Contact CORRINE M BONFIGLIO
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received12/16/2002
Decision Date 09/22/2003
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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