Device Classification Name |
Staple, Implantable
|
510(k) Number |
K201934 |
Device Name |
Surgimatix Absorbable Fixation System |
Applicant |
Surgimatix, Inc. |
1539 Jarvis Ave |
Elk Grove Village,
IL
60007
|
|
Applicant Contact |
Dorene Markwiese |
Correspondent |
Surgimatix, Inc. |
1539 Jarvis Ave |
Elk Grove Village,
IL
60007
|
|
Correspondent Contact |
Dorene Markwiese |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 07/13/2020 |
Decision Date | 10/01/2021 |
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
|
|
|