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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 K121567
Device Name ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
Applicant
ACCEL SPINE
14850 quorum dr ste 220
dallas,  TX  75254
Contact daniel chon
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/31/2012
Decision Date 09/26/2012
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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