OnPoint Augmented Reality Spine System— 510(k) K241870

Name: FDA 510(k) clearance K241870
Creator: U.S. Food and Drug Administration
Published: 2024-08-19

Substantially Equivalent

Onpoint Surgical, Inc.

FDA 510(k) clearance K241870 for OnPoint Augmented Reality Spine System, Substantially Equivalent on 2024-08-19. Applicant: Onpoint Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Onpoint Surgical, Inc.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-06-27
Decision date: 2024-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Concord, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.