OnPoint Augmented Reality Spine System— 510(k) K231284

Name: FDA 510(k) clearance K231284
Creator: U.S. Food and Drug Administration
Published: 2023-09-08

Substantially Equivalent

Onpoint Surgical, Inc.

FDA 510(k) clearance K231284 for OnPoint Augmented Reality Spine System, Substantially Equivalent on 2023-09-08. 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: 2023-05-03
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, 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.