Device Classification Name |
suture, nonabsorbable, synthetic, polyethylene
|
510(k) Number |
K212146 |
Device Name |
Arthrex LoopLoc Knotless Suture |
Applicant |
Arthrex, Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108
|
|
Applicant Contact |
Lai Saeteurn |
Correspondent |
Arthrex, Inc. |
1370 Creekside Boulevard |
Naples,
FL
34108
|
|
Correspondent Contact |
Lai Saeteurn |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 07/09/2021 |
Decision Date | 10/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|