Cleared Traditional

K231284 - OnPoint Augmented Reality Spine System (FDA 510(k) Clearance)

K231284 · Onpoint Surgical, Inc. · Orthopedic device
Sep 2023
Decision
128d
Days
Class 2
Risk

K231284 is an FDA 510(k) clearance for the OnPoint Augmented Reality Spine System. This device is classified as a Orthopedic Augmented Reality (Class II - Special Controls, product code SBF).

Submitted by Onpoint Surgical, Inc. (Bedford, US). The FDA issued a Cleared decision on September 8, 2023, 128 days after receiving the submission on May 3, 2023.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As “augmented Reality” Stereoscopic Images To Intraoperatively Augment The User’s Field Of View..

Submission Details

510(k) Number K231284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2023
Decision Date September 08, 2023
Days to Decision 128 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code SBF - Orthopedic Augmented Reality
Device Class Class II - Special Controls
CFR Regulation 21 CFR 882.4560
Definition An Orthopedic Augmented Reality Device Provides Visual Guidance During Orthopedic Procedures, Where The Use Of Stereotaxic Navigation Is Utilized. Visual Guidance Is Displayed As “augmented Reality” Stereoscopic Images To Intraoperatively Augment The User’s Field Of View.