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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, cervical
510(K) Number K121649
Model 37-3XXX, 37-4XXX,37-5XXX
Device Name CONSTRUX MINI PEEK TI SPACER SYSTEM
Applicant
ORTHOFIX
3451 plano parkway
lewisville,  TX  75056
Contact natalia volosen
Regulation Number888.3080
Classification Product Code
ODP  
Date Received06/05/2012
Decision Date 11/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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