Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K190385 |
Device Name |
CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple 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 Codes |
|
Date Received | 02/19/2019 |
Decision Date | 08/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|