Indius Medical Technologies Pvt., Ltd.
IndiaFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Indius Medical Technologies Pvt., Ltd. makes
Indius Medical Technologies manufactures spinal fixation systems, including the SEA-LINK Anterior Cervical Plate System for cervical spine stabilization and the ACURA Stabilization System for internal fixation in spinal surgeries.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
SEA-LINK Anterior Cervical Plate System Ref K200224
Regimes: 510(k) Registry: 510(k)ACURA Stabilization System Ref K200937
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Indius Medical Technologies Pvt. Ltd. Pune Maharashtra · IN FEI 3014938863
Frequently asked questions
How many devices does Indius Medical Technologies Pvt., Ltd. have in the registry?
The registry currently lists 2 devices for Indius Medical Technologies Pvt., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Indius Medical Technologies Pvt., Ltd.'s devices?
Among its 2 most recently registered devices, Indius Medical Technologies Pvt., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Indius Medical Technologies Pvt., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Indius Medical Technologies Pvt., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Indius Medical Technologies Pvt., Ltd. in the registry?
The most recently registered devices listed for Indius Medical Technologies Pvt., Ltd. include SEA-LINK Anterior Cervical Plate System and ACURA Stabilization System.
Which FDA establishments are linked to Indius Medical Technologies Pvt., Ltd.?
1 FDA establishment is linked to Indius Medical Technologies Pvt., Ltd. in the registry; they are listed on the company page.