Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K190921 |
Device Name |
Arthrex Low Profile Screws |
Applicant |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Applicant Contact |
Heli F. Chambi Infantas |
Correspondent |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Correspondent Contact |
Heli F. Chambi Infantas |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/09/2019 |
Decision Date | 10/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|