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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 K002592
Device Name INTERPORE CROSS ANTERIOR CERVICAL PLATE SYSTEM
Applicant
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Applicant Contact PROSIE REY-FESSLER
Correspondent
Interpore Cross Intl.
181 Technology Dr.
Irvine,  CA  92618
Correspondent Contact PROSIE REY-FESSLER
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received08/21/2000
Decision Date 10/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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