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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 (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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