Device Classification Name |
filler, bone void, osteoinduction (w/o human growth factor)
|
510(k) Number |
K122513 |
Device Name |
CLEARED UNDER GRAFTON II EDBM |
Applicant |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Applicant Contact |
KELLY ANGLIN |
Correspondent |
MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE |
MEMPHIS,
TN
38132
|
|
Correspondent Contact |
KELLY ANGLIN |
Regulation Number | 888.3045
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/17/2012 |
Decision Date | 03/06/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|