Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K121826 |
Device Name |
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM |
Applicant |
ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD |
AUSTIN,
TX
78754
|
|
Applicant Contact |
SUSAN WALTON |
Correspondent |
ASCENSION ORTHOPEDICS, INC. |
8700 CAMERON RD |
AUSTIN,
TX
78754
|
|
Correspondent Contact |
SUSAN WALTON |
Regulation Number | 888.3030
|
Classification Product Code |
|
Date Received | 06/21/2012 |
Decision Date | 02/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|