Device Classification Name |
Pin, Fixation, Smooth
|
510(k) Number |
K121004 |
Device Name |
APEX KIRSCHNER WIRES AND STEINMANN PINS |
Applicant |
APEX TOOLS & ORTHOPEDICS CO. |
1331 H STREET NW 12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Applicant Contact |
HOLLACE SAAS RHODES |
Correspondent |
APEX TOOLS & ORTHOPEDICS CO. |
1331 H STREET NW 12TH FLOOR |
WASHINGTON,
DC
20005
|
|
Correspondent Contact |
HOLLACE SAAS RHODES |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/03/2012 |
Decision Date | 04/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|