FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K Number: K063499
·
Decision Dec 19, 2006
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
593
Applicant Total
6
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
- K Number
- K063499
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Scandius Biomedical, Inc.
- Date Received
- November 20, 2006
- Decision Date
- December 19, 2006
- Product Code
- MBI
- 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 |
|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MBI), ordered by most recent decision date.
Dione PEEK Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
Y-Knotless Flex Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
Anchor with Fiber Wire and Disposable Inserter
FDA 510(k)
FDA Class 2
·Orthopedic
ArthroTAK Tendon Anchor Kit
FDA 510(k)
FDA Class 2
·Orthopedic
Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex FiberTak Suture Anchor
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Scandius Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K063497 | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM | Dec 19, 2006 | Substantially Equivalent |
| K060522 | SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM | Apr 11, 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 |