VERTEFIX PEDICLE SCREW SPINAL SYSTEM— 510(k) K063453

Name: FDA 510(k) clearance K063453
Creator: U.S. Food and Drug Administration
Published: 2007-08-30

Substantially Equivalent

Elite Surgical Supplies (Pty), Ltd.

FDA 510(k) clearance K063453 for VERTEFIX PEDICLE SCREW SPINAL SYSTEM, Substantially Equivalent on 2007-08-30. Applicant: Elite Surgical Supplies (Pty), Ltd.. Device class: 2.

Clearance details

Applicant: Elite Surgical Supplies (Pty), Ltd.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2006-11-15
Decision date: 2007-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, 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.