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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K041407
Device Name TITANIUM MESH IMPLANT
Applicant
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Applicant Contact WENDY SPIELBERGER
Correspondent
INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE,  CA  92618 -2402
Correspondent Contact WENDY SPIELBERGER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/27/2004
Decision Date 12/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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