FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AOS Small Bone Nailing System
K Number: K163014
·
Decision Jan 24, 2017
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
4
Review Days
88
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
- AOS Small Bone Nailing System
- K Number
- K163014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Orthopaedic Solutions, Inc. (Aos)
- Date Received
- October 28, 2016
- Decision Date
- January 24, 2017
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
FDA 510(k)
FDA Class 2
·Orthopedic