FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SBI K-WIRES
K Number: K051605
·
Decision Aug 10, 2005
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
4
Review Days
55
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
- SBI K-WIRES
- K Number
- K051605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Small Bone Innovations, LLC
- Date Received
- June 16, 2005
- Decision Date
- August 10, 2005
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTY), ordered by most recent decision date.
ZipToe Hammertoe Fusion System
FDA 510(k)
FDA Class 2
·Orthopedic
Impact PEEK Union Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
RONAVIS FX (FX-001)
FDA 510(k)
FDA Class 2
·Orthopedic
PediFlex Flexible Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Impact PEEK Union Nail System
FDA 510(k)
FDA Class 2
·Orthopedic
Biomet Kirschner Wires (K-Wires)
FDA 510(k)
FDA Class 2
·Orthopedic