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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 K121581
Model A-BOX, L-BOX
Device Name BOX PEEK VBR SYSTEM,
Applicant
INNOVASIS, INC.
614 east 3900 south
salt lake city,  UT  84107
Contact marshall c mccarty
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/30/2012
Decision Date 10/17/2012
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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