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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 Interlaminal
510(k) Number K022048
Device Name INTERPORE CROSS INTERNATIONAL (ICI) OCCIPITO-CERVICO-THORACIC (OCT) ROD AND PLATE SYSTEM
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618 -2402
Applicant Contact LYNN M RODARTI
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618 -2402
Correspondent Contact LYNN M RODARTI
Regulation Number888.3050
Classification Product Code
KWP  
Date Received06/24/2002
Decision Date 12/04/2002
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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