Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K121148 |
Device Name |
SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D |
Applicant |
MEDICAL DESIGN LLC. |
6709 S. MINNESOTA AVE. STE 204 |
SIOUX FALLS,
SD
57108 -2593
|
|
Applicant Contact |
KRISTI VONDRA |
Correspondent |
MEDICAL DESIGN LLC. |
6709 S. MINNESOTA AVE. STE 204 |
SIOUX FALLS,
SD
57108 -2593
|
|
Correspondent Contact |
KRISTI VONDRA |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/16/2012 |
Decision Date | 08/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|