Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K014155 |
Device Name |
OPENING/CLOSING WEDGE OSTETOMY PLATES |
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 |
|
Date Received | 12/19/2001 |
Decision Date | 03/18/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|