FDA applicant
Indius Medical Technologies Pvt., Ltd.
FDA records 2 decisions for Indius Medical Technologies Pvt., Ltd. (Pune, IN) in 2020: 2 510(k) clearances. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Indius Medical Technologies Pvt., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Indius Medical Technologies Pvt., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report