Regulatory filing
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.
fda 510k · cleared · decided 2018-11-01
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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
Covered models (1)
Sources (2)
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Identity
8a29ffa5-1b3b-4737-ba1b-cda8760297b8