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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 K043316
Device Name RABEA SPINAL IMPLANT
Original Applicant
SIGNUS MEDIZINTECHNIK GMBH
4050 olson memorial hwy
suite 350
minneapolis,  MN  55422
Original Contact tracy l gray
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/02/2004
Decision Date 02/07/2005
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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