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FDA 510(k)

LDR SPINE ROI-C IMPLANT

K-Number: K080728 · 2008-05-29

ApplicantLdr Spine USA
Decision Date2008-05-29
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE ROI-C IMPLANT 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 2008-05-29 under 510(k) number K080728. 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 LDR SPINE ROI-C IMPLANT?

LDR SPINE ROI-C IMPLANT is a medical device that received FDA 510(k) clearance on 2008-05-29. The listed applicant is Ldr Spine USA. The 510(k) number is K080728.

When did LDR SPINE ROI-C IMPLANT receive FDA 510(k) clearance?

LDR SPINE ROI-C IMPLANT received FDA 510(k) clearance on 2008-05-29, under 510(k) number K080728.

Who is the listed applicant for LDR SPINE ROI-C IMPLANT?

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 LDR SPINE ROI-C IMPLANT?

The FDA product code for LDR SPINE ROI-C IMPLANT is MQP.

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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

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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.

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