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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 a medical device manufactured by Onpoint Surgical, Inc.. It received FDA 510(k) clearance on 2023-09-08 under approval 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. It is manufactured by Onpoint Surgical, Inc.. The 510(k) number is K231284.

When was OnPoint Augmented Reality Spine System approved by the FDA?

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

What company makes OnPoint Augmented Reality Spine System?

OnPoint Augmented Reality Spine System is manufactured by Onpoint Surgical, Inc..

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

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

Related Clinical Trials

NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07607899 Virtual Reality for Pain and Well-Being in Older Adults NOT_YET_RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05150197 Virtual Reality Visual Field Testing as an Alternative in Childhood Eye Disease RECRUITING

Related PubMed Literature

PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Onpoint Surgical, Inc.

K241870OnPoint Augmented Reality Spine System

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Official Source

View on FDA Database →

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

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