Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K062747 |
Device Name |
ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM |
Applicant |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Applicant Contact |
ANN WATERHOUSE |
Correspondent |
ARTHREX, INC. |
1370 CREEKSIDE BLVD. |
NAPLES,
FL
34108 -1945
|
|
Correspondent Contact |
ANN WATERHOUSE |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/14/2006 |
Decision Date | 09/29/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|