ARAI Surgical Navigation System— 510(k) K211254

Name: FDA 510(k) clearance K211254
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Surgalign Spine Technologies

FDA 510(k) clearance K211254 for ARAI Surgical Navigation System, Substantially Equivalent on 2022-01-14. Applicant: Surgalign Spine Technologies. Device class: 2.

Clearance details

Applicant: Surgalign Spine Technologies
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2021-04-26
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

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