Device Classification Name |
Pin, Fixation, Smooth
|
510(k) Number |
K201715 |
Device Name |
Smart Toe II, X Fuse |
Applicant |
Stryker GmbH |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Jemin Dedania |
Correspondent |
Stryker GmbH |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Jemin Dedania |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 06/23/2020 |
Decision Date | 08/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|