SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM— 510(k) K052810
Substantially EquivalentScandius Biomedical, Inc.
FDA 510(k) clearance K052810 for SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM, Substantially Equivalent on 2005-12-20. 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
- Traditional
- 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
- K063499 — MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
- K060522 — SCANDIUS TRITIS ABSORBABLE TIBIAL 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.