MODIFICATION TO TENOR SPINAL SYSTEM-PLATES— 510(k) K991364

Substantially Equivalent

Sofamor Danek USA,Inc.

FDA 510(k) clearance K991364 for MODIFICATION TO TENOR SPINAL SYSTEM-PLATES, Substantially Equivalent on 1999-05-19. Applicant: Sofamor Danek USA,Inc..

Clearance details

Applicant: Sofamor Danek USA,Inc.
Product code: Code MNH
Advisory panel: Orthopedic
Date received: 1999-04-20
Decision date: 1999-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, 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.