# fda_510k (us_fda)

FDA 510(k) clearance for TiRobot orthopedic surgical robot. First Chinese surgical robot to receive FDA clearance.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing date: 2016-01-01
- Decision date: 2016-01-01
- Verification posture: verified

## Applicant

- [Tinavi Medical Technologies](/companies/tinavi-medical.md)

## Covered models (1)

- [TiRobot](/models/tinavi-medical-tirobot.md)

## Sources (1)

- [https://www.bioworld.com/articles/726443-ss-innovations-ssi-mantra-surgical-robot-sees-increasing-demand](https://www.bioworld.com/articles/726443-ss-innovations-ssi-mantra-surgical-robot-sees-increasing-demand)

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