Cycla Orthopedics, Ltd.
IsraelFDA 510(k) applicant, unverified
- Devices
- 1
What Cycla Orthopedics, Ltd. makes
Cycla Orthopedics, Ltd. manufactures the CyclaPlex Correction System, a device designed for spinal deformity correction, including scoliosis and other spinal curvatures. This system integrates surgical hardware and techniques to address complex spinal alignment issues in patients.
The company’s portfolio is regulated under Class II devices in the United States, with the CyclaPlex Correction System authorised through the FDA’s 510(k) clearance process. The manufacturer is based in the US and its devices are listed in the FDA’s 510(k) registry.
Catalogue
CyclaPlex Correction System Ref K183094
510(k) 510(k)
Frequently asked questions
How many devices does Cycla Orthopedics, Ltd. have in the registry?
The registry currently lists 1 device for Cycla Orthopedics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cycla Orthopedics, Ltd.'s devices?
Among its 1 most recently registered device, Cycla Orthopedics, Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Cycla Orthopedics, Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cycla Orthopedics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cycla Orthopedics, Ltd. in the registry?
The most recently registered devices listed for Cycla Orthopedics, Ltd. include CyclaPlex Correction System.