Restore Surgical, LLC Dba Instratek
United StatesFDA applicant, unverified
- Devices
- 3
What Restore Surgical, LLC Dba Instratek makes
Restore Surgical, LLC (dba Instratek) manufactures orthopedic fixation devices for foot and toe surgery, including the EasyClip Xpress for soft tissue approximation and two hammertoe correction systems (ToeTac 10° and ToeTac) for bony deformity alignment.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) clearance. The company is based in the United States.
Catalogue
EasyClip Xpress Ref K162321
Regimes: 510(k) Registry: 510(k)ToeTac™ 10° Hammertoe Fixation System Ref K161778
Regimes: 510(k) Registry: 510(k)ToeTac Hammertoe Fixation System Ref K150443
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Restore Surgical, LLC Dba Instratek have in the registry?
The registry currently lists 3 devices for Restore Surgical, LLC Dba Instratek. Devices recorded under merged duplicate company entries are counted once.
Which registries list Restore Surgical, LLC Dba Instratek's devices?
Among its 3 most recently registered devices, Restore Surgical, LLC Dba Instratek has devices listed in FDA 510(k) (3 devices).
What risk classes do Restore Surgical, LLC Dba Instratek's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Restore Surgical, LLC Dba Instratek's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Restore Surgical, LLC Dba Instratek in the registry?
The most recently registered devices listed for Restore Surgical, LLC Dba Instratek include EasyClip Xpress, ToeTac™ 10° Hammertoe Fixation System and ToeTac Hammertoe Fixation System.