AURORA TITANIUM SPINAL ROD SYSTEM— 510(k) K974734

Name: FDA 510(k) clearance K974734
Creator: U.S. Food and Drug Administration
Published: 1998-03-10

Substantially Equivalent

United States Surgical, A Division of Tyco Healthc

FDA 510(k) clearance K974734 for AURORA TITANIUM SPINAL ROD SYSTEM, Substantially Equivalent on 1998-03-10. Applicant: United States Surgical, A Division of Tyco Healthc. Device class: 2.

Clearance details

Applicant: United States Surgical, A Division of Tyco Healthc
Product code: Code MNH
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1997-12-18
Decision date: 1998-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MNH

product code MNH

Injury: 978
Malfunction: 793
Total: 1,771

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.