Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Providence Medical Technology, Inc.. It received FDA 510(k) clearance on 2018-05-18 under 510(k) 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. The listed applicant is Providence Medical Technology, Inc.. The 510(k) number is K180876.

When did DTRAX Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for DTRAX Spinal System?

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

What is the FDA product code for DTRAX Spinal System?

The FDA product code for DTRAX Spinal System is HRX.

Related Clinical Trials

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.

NCT07222787Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion OutcomesRECRUITINGNCT07721493Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative DiseaseNOT_YET_RECRUITING

Other records listing Providence Medical Technology, 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.

K261665CORUS™ Navigation System-GNK253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)K253190CORUS-LX ImplantK251060CORUS™ Navigation System-GXK251885CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantK241035PMT Posterior Cervical Stabilization System (PCSS)

View all 19 devices →

Related Devices (Code: HRX)

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.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC

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.

↑