Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K071105 |
Device Name |
OSTEOMED CALCANEAL PLATE AND SCREW FIXATION SYSTEM |
Applicant |
OSTEOMED L.P. |
3885 ARAPAHO RD. |
ADDISON,
TX
75001
|
|
Applicant Contact |
DAWN D TINDALL |
Correspondent |
OSTEOMED L.P. |
3885 ARAPAHO RD. |
ADDISON,
TX
75001
|
|
Correspondent Contact |
DAWN D TINDALL |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 04/19/2007 |
Decision Date | 07/30/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|