Device Classification Name |
pin, fixation, smooth
|
510(k) Number |
K190287 |
Device Name |
Arthrex DynaNite® PIP (Hammertoe) Implant |
Applicant |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Applicant Contact |
Rebecca R. Homan |
Correspondent |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Correspondent Contact |
Rebecca R. Homan |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 02/11/2019 |
Decision Date | 05/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|