LAGUNA PEDICLE SCREW SYSTEM— 510(k) K050060

Name: FDA 510(k) clearance K050060
Creator: U.S. Food and Drug Administration
Published: 2005-05-04

Substantially Equivalent

Allez Spine, LLC

FDA 510(k) clearance K050060 for LAGUNA PEDICLE SCREW SYSTEM, Substantially Equivalent on 2005-05-04. Applicant: Allez Spine, LLC. Device class: 2.

Clearance details

Applicant: Allez Spine, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2005-01-11
Decision date: 2005-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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K072678 — LAGUNA SIZE 8 PEDICLE SCREW2008-07-02
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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.