# K251316 (us_fda)

FDA 510(k) for Mazor X Stealth robotic-assisted spinal surgery system. Original clearance Nov 2018. K251316 is software enhancement. SpineAssist (2004) was first FDA-approved robotic spine surgery platform.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing number: K251316
- Filing date: 2018-11-01
- Decision date: 2018-11-01
- Verification posture: verified
- Cap-flag notes: Multiple clearances. Original 2018, enhancement K251316.

## Applicant

- [Medtronic](/companies/medtronic.md)

## Covered models (1)

- [Mazor X](/models/mazor-robotics-mazor-x.md)

## Sources (2)

- [https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251316.pdf](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K251316.pdf)
- [https://www.therobotreport.com/mazor-x-stealth-spinal-us/](https://www.therobotreport.com/mazor-x-stealth-spinal-us/)

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