Device Classification Name |
Plate, Fixation, Bone
|
510(k) Number |
K193543 |
Device Name |
CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System |
Applicant |
In2Bones USA, LLC |
6000 Poplar Ave, Suite 115 |
Memphis,
TN
38119
|
|
Applicant Contact |
Christine Scifert |
Correspondent |
In2Bones USA, LLC |
6000 Poplar Ave, Suite 115 |
Memphis,
TN
38119
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2019 |
Decision Date | 01/17/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|