Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K013616 |
Device Name |
POLARUS CAP SCREW |
Applicant |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Applicant Contact |
SHARI JEFFERS |
Correspondent |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Correspondent Contact |
SHARI JEFFERS |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 11/05/2001 |
Decision Date | 12/19/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|