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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, lumbar
510(k) Number K121333
Device Name WAVE D CAGE
Original Applicant
1001 oakwood blvd.
round rock,  TX  78681
Original Contact j.d. webb
Regulation Number888.3080
Classification Product Code
Date Received05/31/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No