AESCULAP SPINE SYSTEM EVOLUTION— 510(k) K980484

Name: FDA 510(k) clearance K980484
Creator: U.S. Food and Drug Administration
Published: 1998-10-02

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K980484 for AESCULAP SPINE SYSTEM EVOLUTION, Substantially Equivalent on 1998-10-02. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 1998-02-09
Decision date: 1998-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, 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.