Device Classification Name |
Component, Traction, Invasive
|
510(k) Number |
K192465 |
Device Name |
DigiFix Sterile Kit |
Applicant |
Virak Orthopedics, LLC |
620 Essex St |
Harrison,
NJ
07029
|
|
Applicant Contact |
Virak Tan |
Correspondent |
MRC-X, LLC |
6075 Poplar Ave Suite 500 |
Memphis,
TN
38119
|
|
Correspondent Contact |
Christine Scifert |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 09/09/2019 |
Decision Date | 10/10/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|