Surgimatix, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Surgimatix, Inc. makes
Surgimatix, Inc. manufactures absorbable surgical staples and fixation systems designed for tissue approximation and wound closure in surgical procedures. The PROXIFAST Absorbable Staple is intended for internal fixation, while the Surgimatix Absorbable Fixation System supports secure tissue attachment that dissolves over time.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. The company is based in the United States.
Catalogue
Proxifast Absorbable Staple Ref K132669
Regimes: 510(k) Registry: 510(k)Surgimatix Absorbable Fixation System Ref K201934
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Surgimatix, Inc. have in the registry?
The registry currently lists 2 devices for Surgimatix, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Surgimatix, Inc.'s devices?
Among its 2 most recently registered devices, Surgimatix, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Surgimatix, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Surgimatix, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Surgimatix, Inc. in the registry?
The most recently registered devices listed for Surgimatix, Inc. include PROXIFAST ABSORBABLE STAPLE and Surgimatix Absorbable Fixation System.