LDR SPINE USA AVENUE L INTERBODY FUSION— 510(k) K113285

Name: FDA 510(k) clearance K113285
Creator: U.S. Food and Drug Administration
Published: 2012-07-26

Substantially Equivalent

Ldr Spine USA, Inc.

FDA 510(k) clearance K113285 for LDR SPINE USA AVENUE L INTERBODY FUSION, Substantially Equivalent on 2012-07-26. Applicant: Ldr Spine USA, Inc.. Device class: 2.

Clearance details

Applicant: Ldr Spine USA, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2011-11-07
Decision date: 2012-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.