PILLAR PEDICLE SCREW SYSTEM— 510(k) K071743

Name: FDA 510(k) clearance K071743
Creator: U.S. Food and Drug Administration
Published: 2007-07-06

Substantially Equivalent

The 4th Column, LLC

FDA 510(k) clearance K071743 for PILLAR PEDICLE SCREW SYSTEM, Substantially Equivalent on 2007-07-06. Applicant: The 4th Column, LLC. Device class: 2.

Clearance details

Applicant: The 4th Column, LLC
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2007-06-27
Decision date: 2007-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.