MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM— 510(k) K063499

Substantially Equivalent

Scandius Biomedical, Inc.

FDA 510(k) clearance K063499 for MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM, Substantially Equivalent on 2006-12-19. Applicant: Scandius Biomedical, Inc..

Clearance details

Applicant: Scandius Biomedical, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2006-11-20
Decision date: 2006-12-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Littleton, MA, US

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Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.