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FDA 510(k)

EASYSPINE SYSTEM

K-Number: K123134 · 2013-02-01

ApplicantLdr Spine USA, Inc.
Decision Date2013-02-01
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EASYSPINE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ldr Spine USA, Inc.. It received FDA 510(k) clearance on 2013-02-01 under 510(k) number K123134. 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 EASYSPINE SYSTEM?

EASYSPINE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Ldr Spine USA, Inc.. The 510(k) number is K123134.

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

EASYSPINE SYSTEM received FDA 510(k) clearance on 2013-02-01, under 510(k) number K123134.

Who is the listed applicant for EASYSPINE SYSTEM?

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

What is the FDA product code for EASYSPINE SYSTEM?

The FDA product code for EASYSPINE SYSTEM is NKB.

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Other records listing Ldr Spine USA, 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.

K162133VerteFIT Corpectomy Cage SystemK161173Avenue® T TLIF CageK161798FacetBRIDGE® SystemK121103LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT SK113285LDR SPINE USA AVENUE L INTERBODY FUSIONK120760LDR SPINE SPINETUNE TL SPINAL 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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