Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K190707 |
Device Name |
Arthrex SoftStitch |
Applicant |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Applicant Contact |
David L Rogers |
Correspondent |
Arthrex Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108 -1945
|
|
Correspondent Contact |
David L Rogers |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 03/19/2019 |
Decision Date | 10/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|