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FDA 510(k)

OARtrac System with Patient Specific Reusable Universal PSD Sensors

K-Number: K162954 · 2017-06-01

ApplicantRadiadyne, LLC
Decision Date2017-06-01
Product CodeNZT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device manufactured by Radiadyne, LLC. It received FDA 510(k) clearance on 2017-06-01 under approval number K162954. The device is classified under product code NZT. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OARtrac System with Patient Specific Reusable Universal PSD Sensors?

OARtrac System with Patient Specific Reusable Universal PSD Sensors is a medical device that received FDA 510(k) clearance on 2017-06-01. It is manufactured by Radiadyne, LLC. The 510(k) number is K162954.

When was OARtrac System with Patient Specific Reusable Universal PSD Sensors approved by the FDA?

OARtrac System with Patient Specific Reusable Universal PSD Sensors received FDA 510(k) clearance on 2017-06-01, under approval number K162954.

What company makes OARtrac System with Patient Specific Reusable Universal PSD Sensors?

OARtrac System with Patient Specific Reusable Universal PSD Sensors is manufactured by Radiadyne, LLC.

What is the FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors?

The FDA product code for OARtrac System with Patient Specific Reusable Universal PSD Sensors is NZT.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026)

Related Devices (Code: NZT)

K182395OARtrac SystemRadialdyne, LLC K250083PRO-DOSE SystemNu-Rise, SA

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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