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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 K122047
Model 22101-XXX, 25101-XXX, 28101-XXX
Device Name ALAMO P
Original Applicant
33490 pin oak parkway
avon lake,  OH  44012
Original Contact jennifer palinchik
Regulation Number888.3080
Classification Product Code
Date Received07/12/2012
Decision Date 09/04/2012
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