Magly Orthopedics, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Magly Orthopedics, LLC makes
Magly Orthopedics, LLC manufactures orthopedic fixation devices, including intramedullary nail systems for long bone stabilization and cannulated screws and locking screws for fracture fixation. These products are designed for internal fixation in orthopedic surgeries, supporting bone alignment and healing.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Apex Intramedullary Nail System Ref K020562
Regimes: 510(k) Registry: 510(k)Magly 6.5mm Cannulated Screws Ref K021662
Regimes: 510(k) Registry: 510(k)Magly 4.0 And 5.5 Mm Locking System Ref K021579
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Magly Orthopedics, LLC have in the registry?
The registry currently lists 3 devices for Magly Orthopedics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Magly Orthopedics, LLC's devices?
Among its 3 most recently registered devices, Magly Orthopedics, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Magly Orthopedics, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Magly Orthopedics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Magly Orthopedics, LLC in the registry?
The most recently registered devices listed for Magly Orthopedics, LLC include APEX INTRAMEDULLARY NAIL SYSTEM, MAGLY 6.5MM CANNULATED SCREWS and MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM.