MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM— 510(k) K063499
Substantially EquivalentScandius 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.. Device class: 2.
Clearance details
- Applicant
- Scandius Biomedical, Inc.
- Product code
- Code MBI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Littleton, MA, US
Recent devices under product code MBI
view allMore clearances from Scandius Biomedical, Inc.
view all- K063497 — MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
- K060522 — SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
- K052810 — SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
- K041961 — SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
- K041749 — SCANDIUS ACL RECONSTRUCTION SYSTEM
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
Source: openFDA MAUDE database, through . 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.