Intelligent Orthopaedics, Ltd.
United KingdomFDA applicant, unverified
- Devices
- 3
What Intelligent Orthopaedics, Ltd. makes
Intelligent Orthopaedics, Ltd. manufactures sterile surgical kits and external fixation systems for orthopaedic procedures, including the STERILE STORM® Operating Kit, the STORM Operating Kit (Model 1-10-0), and the IOS External Fixator (Model 2-0-0). These products are designed for use in orthopaedic surgeries and fracture stabilization.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The portfolio is authorised for commercial distribution in the United States.
Catalogue
Sterile Storm (R) Operating Kit Ref K111001
Regimes: 510(k) Registry: 510(k)Storm Operating Kit, Model 1-10-0 Ref K061607
Regimes: 510(k) Registry: 510(k)Ios External Fixator, Model 2-0-0 Ref K070724
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Intelligent Orthopaedics, Ltd. have in the registry?
The registry currently lists 3 devices for Intelligent Orthopaedics, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Intelligent Orthopaedics, Ltd.'s devices?
Among its 3 most recently registered devices, Intelligent Orthopaedics, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Intelligent Orthopaedics, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Intelligent Orthopaedics, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Intelligent Orthopaedics, Ltd. in the registry?
The most recently registered devices listed for Intelligent Orthopaedics, Ltd. include STERILE STORM (R) OPERATING KIT, STORM OPERATING KIT, MODEL 1-10-0 and IOS EXTERNAL FIXATOR, MODEL 2-0-0.