Device Classification Name |
filler, bone void, calcium compound
|
510(k) Number |
K121453 |
Device Name |
A-GRIX TE RESORABLE BONE VOID FILLER |
Applicant |
AG DIGITAL TECHNOLOGY CORP. |
2904 N. BOLDT DRIVE |
FLAGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
AG DIGITAL TECHNOLOGY CORP. |
2904 N. BOLDT DRIVE |
FLAGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 888.3045
|
Classification Product Code |
|
Date Received | 05/16/2012 |
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
|
|
|