Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K120015 |
Device Name |
OSTEOMED WRIST PLATING SYSTEM |
Applicant |
OSTEOMED LP |
3885 Arapaho Rd |
ADDISON,
TX
75001
|
|
Applicant Contact |
SUZANNE CHEANG |
Correspondent |
OSTEOMED LP |
3885 Arapaho Rd |
ADDISON,
TX
75001
|
|
Correspondent Contact |
SUZANNE CHEANG |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/03/2012 |
Decision Date | 04/24/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|