Device Classification Name |
orthosis, spondylolisthesis spinal fixation
|
510(k) Number |
K101374 |
Device Name |
AAXTER A3 POSTERIOR SPINAL SYSTEM |
Applicant |
AAXTER CO., LTD |
NO. 8-3, SEC. , JHONGSING RD., |
WUGU TOWNSHIP |
TAIPEI,
TW
24872
|
|
Applicant Contact |
JACK CHEN |
Correspondent |
AAXTER CO., LTD |
NO. 8-3, SEC. , JHONGSING RD., |
WUGU TOWNSHIP |
TAIPEI,
TW
24872
|
|
Correspondent Contact |
JACK CHEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 05/17/2010 |
Decision Date | 03/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|