ARAI Surgical Navigation System— 510(k) K211254

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.

Clearance details

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

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