Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K112675 |
Device Name |
ARROW-LOK DIGITAL SYSTEM |
Applicant |
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC |
328 POPLAR VIEW LANE EAST |
SUITE 2 |
COLLIERVILLE,
TN
38017
|
|
Applicant Contact |
THOMAS J TWARDZIK |
Correspondent |
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC |
328 POPLAR VIEW LANE EAST |
SUITE 2 |
COLLIERVILLE,
TN
38017
|
|
Correspondent Contact |
THOMAS J TWARDZIK |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/14/2011 |
Decision Date | 12/12/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|