GII SPINAL FIXATION SYSTEM— 510(k) K980852

Substantially Equivalent

Karen E. Warden, M.E.B.E.

FDA 510(k) clearance K980852 for GII SPINAL FIXATION SYSTEM, Substantially Equivalent on 1998-05-01. Applicant: Karen E. Warden, M.E.B.E..

Clearance details

Applicant: Karen E. Warden, M.E.B.E.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1998-03-05
Decision date: 1998-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

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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.