FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5— 510(k) K042713

Name: FDA 510(k) clearance K042713
Creator: U.S. Food and Drug Administration
Published: 2004-12-29

Substantially Equivalent

Spine Next America Corporation

FDA 510(k) clearance K042713 for FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5, Substantially Equivalent on 2004-12-29. Applicant: Spine Next America Corporation. Device class: 2.

Clearance details

Applicant: Spine Next America Corporation
Product code: Code MQP
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2004-09-30
Decision date: 2004-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

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K042714 — FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 1, 2, 3 AND 42004-12-29

Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.