The following data is part of a premarket notification filed by Surgimatix, Inc. with the FDA for Surgimatix Absorbable Fixation System.
| Device ID | K201934 |
| 510k Number | K201934 |
| Device Name: | Surgimatix Absorbable Fixation System |
| Classification | Staple, Implantable |
| Applicant | Surgimatix, Inc. 1539 Jarvis Ave Elk Grove Village, IL 60007 |
| Contact | Dorene Markwiese |
| Correspondent | Dorene Markwiese Surgimatix, Inc. 1539 Jarvis Ave Elk Grove Village, IL 60007 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2021-10-01 |