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EasySpine System

by LDR Spine Usa, Inc.

510(k) K123134

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK123134 Date1 Feb 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NKB
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The EasySpine System is a posterior spinal osteosynthesis device classified under product code NKB, designed for immobilization and stabilization of spinal segments in skeletally mature patients. It is intended as an adjunct to fusion for treating acute and chronic spinal conditions in the thoracic and lumbar regions, including both pedicle and non-pedicle fixation. The system is engineered to enhance surgical reproducibility and patient comfort through innovative technical solutions. Its design supports secure fixation while minimizing procedural variability.

This system is supplied as a surgical implant and is regulated under FDA 510(k) clearance (K123134) as a substantially equivalent device, reviewed by the Orthopedic (OR) Advisory Committee. It is intended for single-use in controlled surgical environments and must be handled according to sterile procedures. The device is not MRI-safe and requires proper storage to maintain integrity. Authorizations are specific to the United States, adhering to FDA traditional clearance pathways for orthopedic spinal fixation systems.

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Questions

AI-generated answers, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of spinal conditions is the EasySpine System intended to address in the thoracic and lumbar regions?

    The EasySpine System is designed as an adjunct to spinal fusion for stabilizing and immobilizing spinal segments in skeletally mature patients. It is specifically intended for treating both acute and chronic spinal conditions in the thoracic and lumbar regions, including cases requiring pedicle or non-pedicle fixation. Its purpose is to enhance surgical precision and patient comfort while ensuring secure fixation.

  • Is the EasySpine System reusable, or is it meant for single-use in surgery?

    The EasySpine System is explicitly intended for single-use in controlled surgical environments. This designation aligns with standard sterile medical device protocols to ensure patient safety and prevent cross-contamination. Proper sterile handling is required during use.

  • How should the EasySpine System be stored to maintain its integrity?

    The EasySpine System must be stored under conditions that preserve its structural integrity, as specified for single-use orthopedic implants. While exact storage instructions aren’t detailed in the data, typical guidelines for such devices include protection from moisture, extreme temperatures, and physical damage. Always follow manufacturer-provided packaging guidelines to ensure sterility and functionality until use.

  • Can the EasySpine System be used with MRI imaging after implantation, or does it pose safety concerns?

    The EasySpine System is not MRI-safe, meaning it should not be used in patients who require MRI imaging post-surgery. The device’s materials or design may interfere with MRI scans, posing risks to both the patient and the imaging equipment. Pre-procedure planning should account for this limitation.

  • What regulatory pathway was followed for FDA clearance of the EasySpine System, and what does that mean for clinicians?

    The EasySpine System received FDA clearance through a 510(k) submission (K123134), classified as substantially equivalent to a predicate device under product code NKB. The review was conducted by the Orthopedic (OR) Advisory Committee using the traditional clearance pathway, ensuring compliance with U.S. orthopedic spinal fixation standards. This means clinicians can rely on its safety and performance as determined by FDA standards for similar devices.