FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K Number: K060522
·
Decision Apr 11, 2006
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
219
Applicant Total
6
Review Days
43
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Basic Information
- Device Name
- SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
- K Number
- K060522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scandius Biomedical, Inc.
- Date Received
- February 27, 2006
- Decision Date
- April 11, 2006
- Product Code
- MAI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | FDA class 2 | Orthopedic |
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Other Clearances by Scandius Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063499 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Dec 19, 2006 | Substantially Equivalent |
| K063497 | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM | Dec 19, 2006 | Substantially Equivalent |
| K052810 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM | Dec 20, 2005 | Substantially Equivalent |
| K041961 | SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM | Oct 20, 2004 | Substantially Equivalent |
| K041749 | SCANDIUS ACL RECONSTRUCTION SYSTEM | Sep 8, 2004 | Substantially Equivalent |