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)

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)

K-Number: K043349 · 2005-06-29

ApplicantLdr Spine USA
Decision Date2005-06-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA. It received FDA 510(k) clearance on 2005-06-29 under 510(k) number K043349. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)?

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) is a medical device that received FDA 510(k) clearance on 2005-06-29. The listed applicant is Ldr Spine USA. The 510(k) number is K043349.

When did OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) receive FDA 510(k) clearance?

OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) received FDA 510(k) clearance on 2005-06-29, under 510(k) number K043349.

Who is the listed applicant for OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)?

The FDA 510(k) record lists Ldr Spine USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)?

The FDA product code for OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) is MQP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ldr Spine USA 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.

K153495Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant SystemK152137FacetBRIDGE SystemK110327LDR SPINE ROI-A INTERBODY FUSION SYSTEMK102331LDR SPINE USA SPINETUNE TL SPINAL SYSTEMK102265LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEMK100575LDR SPINE USA SPINE TUNE TL SPINE SYSTEM

View all 23 devices →

Related Devices (Code: MQP)

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.

K261810Vertiwedge® Intraosseous SystemFoundation Surgical GroupK261031POSEIDON STSignus Medinzintechnik GmbHK253158VyBrate™ VBR SystemVy Spine, LLCK241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AGK233359DOMINION Expandable Corpectomy SystemAstura Medical

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.

↑