Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K122334 |
Device Name |
CHECKMATE SMALL BONE FUSION SYSTEM |
Applicant |
ARTHROSURFACE, INC. |
28 FORGE PARKWAY |
FRANKLIN,
MA
02038
|
|
Applicant Contact |
DAWN J WILSON |
Correspondent |
ARTHROSURFACE, INC. |
28 FORGE PARKWAY |
FRANKLIN,
MA
02038
|
|
Correspondent Contact |
DAWN J WILSON |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/02/2012 |
Decision Date | 11/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|