EASYSPINE SYSTEM— 510(k) K061017

Name: FDA 510(k) clearance K061017
Creator: U.S. Food and Drug Administration
Published: 2006-08-10

Substantially Equivalent

Ldr Spine USA

FDA 510(k) clearance K061017 for EASYSPINE SYSTEM, Substantially Equivalent on 2006-08-10. Applicant: Ldr Spine USA. Device class: 2.

Clearance details

Applicant: Ldr Spine USA
Product code: Product code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2006-04-13
Decision date: 2006-08-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNI

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K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

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K152137 — FacetBRIDGE System2016-01-25
K151934 — ROI-C Titanium-Coated Implant System2015-12-07
K150765 — LDR Spine ROI-C Cervical Cage System2015-09-17
K110327 — LDR SPINE ROI-A INTERBODY FUSION SYSTEM2011-09-30

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.