Genesis Fracture Care, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Genesis Fracture Care, Inc. makes
Genesis Fracture Care, Inc. manufactures orthopedic fixation plates designed for bone fracture stabilization, including large fragment, small fragment, and miniature systems. These plates are intended for internal fixation in long bone fractures, providing secure alignment and support during the healing process.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, reflecting their compliance with U.S. regulatory requirements. The company operates from the United States.
Catalogue
G3 Active Plate Large Fragment System Ref K142938
Regimes: 510(k) Registry: 510(k)G3 Active Plate Large Fragment System Ref K150649
Regimes: 510(k) Registry: 510(k)G3(TM) Active Plate(R) Small Fragment System Ref K160633
Regimes: 510(k) Registry: 510(k)G3™ Active Plate® Miniature System Ref K171293
Regimes: 510(k) Registry: 510(k)G3¿ Active Plate® Large Fragment System Ref K152242
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Genesis Fracture Care, Inc. have in the registry?
The registry currently lists 5 devices for Genesis Fracture Care, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Genesis Fracture Care, Inc.'s devices?
Among its 5 most recently registered devices, Genesis Fracture Care, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Genesis Fracture Care, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Genesis Fracture Care, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Genesis Fracture Care, Inc. in the registry?
The most recently registered devices listed for Genesis Fracture Care, Inc. include G3 Active Plate Large Fragment System, G3(TM) Active Plate(R) Small Fragment System, G3™ Active Plate® Miniature System and G3¿ Active Plate® Large Fragment System.