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FDA 510(k)

LDR SPINE EASYSPINE SYSTEM

K-Number: K082592 · 2008-10-08

ApplicantLdr Spine USA
Decision Date2008-10-08
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LDR SPINE EASYSPINE SYSTEM 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 2008-10-08 under 510(k) number K082592. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDR SPINE EASYSPINE SYSTEM?

LDR SPINE EASYSPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-10-08. The listed applicant is Ldr Spine USA. The 510(k) number is K082592.

When did LDR SPINE EASYSPINE SYSTEM receive FDA 510(k) clearance?

LDR SPINE EASYSPINE SYSTEM received FDA 510(k) clearance on 2008-10-08, under 510(k) number K082592.

Who is the listed applicant for LDR SPINE EASYSPINE SYSTEM?

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 EASYSPINE SYSTEM?

The FDA product code for LDR SPINE EASYSPINE SYSTEM is NKB.

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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: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

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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