Innosys Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 5
What Innosys Co., Ltd. makes
Innosys Co., Ltd. manufactures spinal navigation instruments, including the INNOVERSE Navigation Instruments, and spinal fixation systems such as the ANAX™ 5.5 Spinal System and the INNOVERSE Spinal System. The company also produces the UniSpace® Stand-Alone C Cage, a standalone cervical cage for spinal stabilization.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
INNOVERSE Navigation Instruments Ref K241082
Regimes: 510(k) Registry: 510(k)ANAX™ 5.5 Spinal System Ref K231737
Regimes: 510(k) Registry: 510(k)Dyna Locking Trochanteric Nail™ Ref K221084
Regimes: 510(k) Registry: 510(k)INNOVERSE Spinal System Ref K233960
Regimes: 510(k) Registry: 510(k)UniSpace® Stand-Alone C Cage Ref K234119
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Innosys Co., Ltd. have in the registry?
The registry currently lists 5 devices for Innosys Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Innosys Co., Ltd.'s devices?
Among its 5 most recently registered devices, Innosys Co., Ltd. has devices listed in FDA 510(k) (5 devices).
What risk classes do Innosys Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Innosys Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Innosys Co., Ltd. in the registry?
The most recently registered devices listed for Innosys Co., Ltd. include INNOVERSE Navigation Instruments, ANAX™ 5.5 Spinal System, Dyna Locking Trochanteric Nail™ and INNOVERSE Spinal System.