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FDA 510(k)

OnPoint Augmented Reality Spine System

K-Number: K231284 · 2023-09-08

ApplicantOnpoint Surgical, Inc.
Decision Date2023-09-08
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

OnPoint Augmented Reality Spine System is the device name listed in this FDA 510(k) record. The listed applicant is Onpoint Surgical, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231284. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OnPoint Augmented Reality Spine System?

OnPoint Augmented Reality Spine System is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Onpoint Surgical, Inc.. The 510(k) number is K231284.

When did OnPoint Augmented Reality Spine System receive FDA 510(k) clearance?

OnPoint Augmented Reality Spine System received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231284.

Who is the listed applicant for OnPoint Augmented Reality Spine System?

The FDA 510(k) record lists Onpoint Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OnPoint Augmented Reality Spine System?

The FDA product code for OnPoint Augmented Reality Spine System is SBF.

Other records listing Onpoint Surgical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241870OnPoint Augmented Reality Spine System

Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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