Regulatory filing

fda_510k (us_fda)

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

fda 510k · cleared · decided 2016-01-01

Track fda_510k (us_fda)

Machine-readable surfaces

Markdown mirror: /regulatory-filings/tinavi-tirobot-fda-510k.md
JSON-LD: embedded in this page’s head
REST API: /v1/filings/843572a1-9a07-4f61-b3ec-39d6941466ac
Revision history: /regulatory-filings/tinavi-tirobot-fda-510k/history
Data documentation: /data
Query this programmatically: Deploy MCP

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

Covered models (1)

TiRobot

Sources (1)

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

Deploy Watch

Track fda_510k (us_fda).

We notify you when the filing status changes or related filings, incidents, or litigations surface.

Identity

843572a1-9a07-4f61-b3ec-39d6941466ac