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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 K122444
Device Name CERVICAL CAGE
Applicant
EISERTECH, LLC
1133 columbia street
suite 107
san diego,  CA  92101
Contact lukas eisermann
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/10/2012
Decision Date 08/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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