Data / Medical devices / Thoracolumbosacral Pedicle Screw System / India
FDA-registered makers of Thoracolumbosacral Pedicle Screw System in India: 5 establishments
5 establishments in India are registered with the FDA to make Thoracolumbosacral Pedicle Screw System (product code NKB). 5 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Thoracolumbosacral Pedicle Screw System
- Product code
- NKB
- Country
- India
Makers of Thoracolumbosacral Pedicle Screw System in India
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Solco Biomedical Company India Private Limited | KADI Gujarat, India | Contract manufacturer, Manufacturer | 2 | February 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Auxein medical Private limited | Sonipat Haryana, India | Manufacturer | 1 | April 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| GPC Medical Limited | Ghaziabad Uttar Pradesh, India | Manufacturer | 1 | March 31, 2017 | 0 | 0 | 0 | api.fda.gov |
| Greens Surgicals Private Limited | Vadodara Gujarat, India | Manufacturer | 1 | October 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Indius Medical Technologies Pvt. Ltd. | Pune Maharashtra, India | Complaint file establishment, Manufacturer | 1 | October 26, 2020 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.