SPINE FIXATION— 510(k) K943827

Substantially Equivalent for Some Indications

Danek Medical, Inc.

FDA 510(k) clearance K943827 for SPINE FIXATION, Substantially Equivalent for Some Indications on 1996-02-14. Applicant: Danek Medical, Inc..

Clearance details

Applicant: Danek Medical, Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1994-08-05
Decision date: 1996-02-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.