FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
K Number: K222967
·
Decision Nov 23, 2022
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
3
Review Days
57
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
- Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
- K Number
- K222967
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Avanti Orthopaedics, Inc.
- Date Received
- September 27, 2022
- Decision Date
- November 23, 2022
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic