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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 K982006
Device Name MICOMED - HALM ZIELKE INSTRUMENTATION
Applicant
Micomed GmbH
511 Catalina Rd.
Fullerton,  CA  92835
Applicant Contact CHARMAINE HENDERSON
Correspondent
Micomed GmbH
511 Catalina Rd.
Fullerton,  CA  92835
Correspondent Contact CHARMAINE HENDERSON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received06/08/1998
Decision Date 01/20/1999
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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