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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 K050997
Device Name EXPANSE VERTEBRAL BODY REPLACEMENT DEVICE
Applicant
FLEXUSPINE, INC.
120 W. FIFTH STREET, SUITE 200
TYLER,  TX  75701
Applicant Contact COREY HARBOLD
Correspondent
FLEXUSPINE, INC.
120 W. FIFTH STREET, SUITE 200
TYLER,  TX  75701
Correspondent Contact COREY HARBOLD
Regulation Number888.3060
Classification Product Code
MQP  
Date Received04/20/2005
Decision Date 10/07/2005
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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