MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM— 510(k) K063497

Substantially Equivalent

Scandius Biomedical, Inc.

FDA 510(k) clearance K063497 for MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM, Substantially Equivalent on 2006-12-19. Applicant: Scandius Biomedical, Inc..

Clearance details

Applicant: Scandius Biomedical, Inc.
Product code: Code MAI
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 MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.