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FDA 510(k)

DTRAX Spinal System

K-Number: K180876 · 2018-05-18

ApplicantProvidence Medical Technology, Inc.
Decision Date2018-05-18
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DTRAX Spinal System is a medical device manufactured by Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-05-18 under approval number K180876. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DTRAX Spinal System?

DTRAX Spinal System is a medical device that received FDA 510(k) clearance on 2018-05-18. It is manufactured by Providence Medical Technology, Inc.. The 510(k) number is K180876.

When was DTRAX Spinal System approved by the FDA?

DTRAX Spinal System received FDA 510(k) clearance on 2018-05-18, under approval number K180876.

What company makes DTRAX Spinal System?

DTRAX Spinal System is manufactured by Providence Medical Technology, Inc..

What is the FDA product code for DTRAX Spinal System?

The FDA product code for DTRAX Spinal System is HRX.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

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Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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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