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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name filler, bone void, calcium compound
510(k) Number K121453
Device Name A-GRIX TE RESORABLE BONE VOID FILLER
Original Applicant
AG DIGITAL TECHNOLOGY CORP.
2904 n. boldt drive
flagstaff,  AZ  86001
Original Contact jennifer reich
Regulation Number888.3045
Classification Product Code
MQV  
Date Received05/16/2012
Decision Date 02/05/2013
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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