FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
K Number: K092803
·
Decision Dec 23, 2009
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
3
Review Days
103
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
- CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
- K Number
- K092803
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardo Medical Corp.
- Date Received
- September 11, 2009
- Decision Date
- December 23, 2009
- Product Code
- JWH
- 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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWH), ordered by most recent decision date.
NovoKnee (SteriKnee)
FDA 510(k)
FDA Class 2
·Orthopedic
Materialise TKA Guide System
FDA 510(k)
FDA Class 2
·Orthopedic
EMPOWR Knee
FDA 510(k)
FDA Class 2
·Orthopedic
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom Infinia Total Knee System
FDA 510(k)
FDA Class 2
·Orthopedic
Freedom® Total Knee System Titan PCK Components
FDA 510(k)
FDA Class 2
·Orthopedic