Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K031666 |
Device Name |
ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS |
Applicant |
ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. |
NAPLES,
FL
34104
|
|
Applicant Contact |
ANN WATERHOUSE |
Correspondent |
ARTHREX, INC. |
2885 SOUTH HORSESHOE DR. |
NAPLES,
FL
34104
|
|
Correspondent Contact |
ANN WATERHOUSE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/29/2003 |
Decision Date | 11/18/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|