Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K183363 |
Device Name |
Treace Medical Concepts (TMC) Snap-Off Screw System |
Applicant |
Treace Medical Concepts, Inc. |
203 Fort Wade Rd., |
Suite 150 |
Ponte Vedra,
FL
32081
|
|
Applicant Contact |
Rachel Osbeck |
Correspondent |
MRC-X, LLC |
6075 Poplar Avenue, |
Suite 500 |
Memphis,
TN
38119
|
|
Correspondent Contact |
Dawn Norman |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 12/04/2018 |
Decision Date | 06/13/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|